The efficacy of duct tape vs cryotherapy in the treatment of verruca vulgaris (the common wart). Topical 5-fluorouracil has no additional benefit in treating common warts with cryotherapy: a single-centre, double-blind, randomized, placebo-controlled trial. Multicentre intraindividual randomized trial of topical methyl aminolaevulinate-photodynamic therapy vs. cryotherapy for multiple actinic keratoses on the extremities. Cryotherapy with liquid nitrogen versus topical salicylic acid application for cutaneous warts in primary care: randomized controlled trial. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. Modern treatment of warts: cure rates at 3 and 6 months. [595 nm pulse dye laser therapy for viral warts: a single-blind randomized comparative study versus placebo]. Value of a second freeze-thaw cycle in cryotherapy of common warts. Efficacy of duct tape vs placebo in the treatment of verruca vulgaris (warts) in primary school children. Efficacy of 80% phenol solution in comparison with cryotherapy in the treatment of common warts of hands. Intraindividual, right-left comparison of topical methyl aminolaevulinate-photodynamic therapy and cryotherapy in subjects with actinic keratoses: a multicentre, randomized controlled study. Photodynamic therapy (PDT) and waterfiltered infrared A (wIRA) in patients with recalcitrant common hand and foot warts. Compared therapeutic efficacy between intralesional bleomycin and cryotherapy for common warts: a randomized clinical trial. An assessment of methods of treating viral warts by comparative treatment trials based on a standard design. Cryotherapy versus salicylic acid for the treatment of plantar warts (verrucae): a randomised controlled trial. Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: A prospective, randomized study. Duct tape for the treatment of common warts in adults: a double-blind randomized controlled trial. Facial resurfacing for nonmelanoma skin cancer prophylaxis. Prospective study of pulsed dye laser in conjunction with cryogen spray cooling for treatment of port wine stains in Chinese patients. Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results. Effect of pilocarpine during radiation therapy: results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. Oral cooling (cryotherapy), an effective treatment for the prevention of 5-fluorouracil-induced stomatitis. Comparison of topical methyl aminolevulinate photodynamic therapy with cryotherapy or Fluorouracil for treatment of squamous cell carcinoma in situ: Results of a multicenter randomized trial. [Cutaneous cryosurgery in family medicine: dimethyl ether-propane spray versus liquid nitrogen]. Photodynamic therapy with 5-aminolaevulinic acid or placebo for recalcitrant foot and hand warts: randomised double-blind trial. Cryopreserved and lyophilized cultured epidermal allografts in the treatment of leg ulcers: a pilot study. Efficacy of imiquimod as an adjunct to cryotherapy for actinic keratoses. A randomized clinical trial of two different durations of oral cryotherapy for prevention of 5-fluorouracil-related stomatitis. Intralesional bleomycin in the treatment of cutaneous warts: a randomized clinical trial comparing it with cryotherapy. Effects of hypnotic, placebo, and salicylic acid treatments on wart regression. Laser or cryotherapy for cervical intraepithelial neoplasia: a randomized study to compare efficacy and side effects. Evaluation of lidocaine as an analgesic when added to hypertonic saline for sclerotherapy. Cryotherapy of common viral warts at intervals of 1, 2 and 3 weeks. Comparison of photodynamic therapy with cryotherapy in the treatment of Bowen's disease. Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies. Optimization of photodynamic therapy with a novel self-adhesive 5-aminolaevulinic acid patch: results of two randomized controlled phase III studies. [Clinical observation on effect of shenqi fanghou recipe in preventing and treating radiation injury in patients with head and neck tumor]. Treatment of actinic keratoses on the dorsum of the hands: ALA-PDT versus diclofenac 3% gel followed by ALA-PDT. A placebo-controlled, double-blind, pilot study. Photodynamic therapy of multiple actinic keratoses: reduced pain through use of visible light plus water-filtered infrared A compared with light from light-emitting diodes. A randomised study of topical 5% imiquimod vs. topical 5-fluorouracil vs. cryosurgery in immunocompetent patients with actinic keratoses: a comparison of clinical and histological outcomes including 1-year follow-up. Pulsed-dye laser versus conventional therapy in the treatment of warts: a prospective randomized trial. Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms. Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy study. Results of a randomized phase-III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant metastatic prostate cancer. One-week treatment with 0.5% fluorouracil cream prior to cryosurgery in patients with actinic keratoses: a double-blind, vehicle-controlled, long-term study. A randomised multicentre trial of CHART versus conventional radiotherapy in head and neck cancer. Use of topical misoprostol to reduce radiation-induced mucositis: results of a randomized, double-blind, placebo-controlled trial. Phase III controlled evaluation of sucralfate to alleviate stomatitis in patients receiving fluorouracil-based chemotherapy. Management of intravaginal warts in women with 5-fluorouracil (1%) in vaginal hydrophilic gel: a placebo-controlled double-blind study. Foam-sclerotherapy, surgery, sclerotherapy, and combined treatment for varicose veins: a 10-year, prospective, randomized, controlled, trial (VEDICO trial). Betamethasone valerate foam 0.12%: a novel vehicle with enhanced delivery and efficacy. Efficacy of commercially available topical cyclosporine A 0.05% in the treatment of meibomian gland dysfunction. [Cryotherapy as analgesic technique in direct, postoperative treatment following elective joint replacement]. Comparison of ultrasound and ketoprofen phonophoresis in the treatment of carpal tunnel syndrome.
To determine if application of duct tape is as effective as cryotherapy in the treatment of common warts.
                A prospective, randomized controlled trial with 2 treatment arms for warts in children.
                The general pediatric and adolescent clinics at a military medical center.
                A total of 61 patients (age range, 3-22 years) were enrolled in the study from October 31, 2000, to July 25, 2001; 51 patients completed the study and were available for analysis.
                Patients were randomized using computer-generated codes to receive either cryotherapy (liquid nitrogen applied to each wart for 10 seconds every 2-3 weeks) for a maximum of 6 treatments or duct tape occlusion (applied directly to the wart) for a maximum of 2 months. Patients had their warts measured at baseline and with return visits.
                Complete resolution of the wart being studied.
                Of the 51 patients completing the study, 26 (51%) were treated with duct tape, and 25 (49%) were treated with cryotherapy. Twenty-two patients (85%) in the duct tape arm vs 15 patients (60%) enrolled in the cryotherapy arm had complete resolution of their warts (P =.05 by chi(2) analysis). The majority of warts that responded to either therapy did so within the first month of treatment.
                Duct tape occlusion therapy was significantly more effective than cryotherapy for treatment of the common wart. The role of topical 5-fluorouracil (5-FU) in treating common warts is not well defined. We tried to evaluate the efficacy and adverse effects of combination cryotherapy and topical 5% 5-FU ointment in the treatment of common warts. The study was a single-centre, double-blind randomized placebo-controlled trial. In the study, 80 patients with common warts were randomized into two groups and underwent two 10-second freeze/thaw cycles of cryotherapy with liquid nitrogen once every three weeks for a maximum of five treatments. Between treatments, patients applied either topical 5% 5-FU ointment (group A) or placebo aqueous cream (group B) twice daily. The mean +/- SD reduction in wart area was 58.57 +/- 0.06% in group A and 65.29 +/- 0.06% in group B. In total, 19 patients in group A and 24 patients in group B had wart size reduced by 75% or more (P = 0.50), while 12 patients in group A and 17 patients in group B had clearance of their warts (P = 0.245). Logistic regression with age, sex, smoking status, immune status, site, duration and number of warty lesions, history of previous treatment, and treatment group found that only a history of previous treatment and acral lesions were significant adverse predictors of improvement. There was no significant difference in the number of adverse events between the two groups, although there was a trend towards more pain and blistering associated with topical 5-FU. We concluded that topical 5-FU has no added benefit in treating common warts with cryotherapy. Methyl aminolaevulinate-photodynamic therapy (MAL-PDT) is an effective treatment in facial/scalp actinic keratosis (AK).
                The aims of this study were to compare efficacy, safety, cosmetic outcome and patient preference of MAL-PDT vs. cryotherapy in patients with AK at other locations.
                A multicentre, controlled, randomized, open, intraindividual, right-left comparison was performed. Patients with nonhyperkeratotic AK were treated once with MAL-PDT and cryotherapy on either side of the body. At week 12, lesions showing noncomplete response were retreated. The primary efficacy variable was the lesion response at week 24. Investigator's assessment of cosmetic outcome, patient's preference in terms of cosmetic outcome and a patient preference questionnaire were also analysed at week 24.
                In total, of 121 patients with 1343 lesions (98% located on the extremities and the remainder on the trunk and neck) were included. Both treatments provided a high mean percentage reduction in lesion count at week 24 with significantly higher efficacy for cryotherapy: 78% for MAL-PDT and 88% for cryotherapy (P=0.002, per protocol population). Investigator's assessment of cosmetic outcome was significantly better for MAL-PDT than cryotherapy (P<0.001), 79% of lesions having an excellent cosmetic outcome with MAL-PDT vs. 56% with cryotherapy at week 24. The cosmetic outcome achieved by MAL-PDT compared with cryotherapy was also preferred by patients (50% vs. 22%, respectively, P<0.001), and 59% of patients would prefer to have any new lesions treated with MAL-PDT compared with 25% with cryotherapy (P<0.001). Both treatment regimens were safe and well tolerated.
                MAL-PDT showed inferior efficacy for treatment of non-face/scalp AK compared with cryotherapy. However, both treatments showed high efficacy, and MAL-PDT conveyed the advantages of better cosmesis and higher patient preference. Cryotherapy is widely used for the treatment of cutaneous warts in primary care. However, evidence favours salicylic acid application. We compared the effectiveness of these treatments as well as a wait-and-see approach.
                Consecutive patients with new cutaneous warts were recruited in 30 primary care practices in the Netherlands between May 1, 2006, and Jan. 26, 2007. We randomly allocated eligible patients to one of three groups: cryotherapy with liquid nitrogen every two weeks, self-application of salicylic acid daily or a wait-and-see approach. The primary outcome was the proportion of participants whose warts were all cured at 13 weeks. Analysis was on an intention-to-treat basis. Secondary outcomes included treatment adherence, side effects and treatment satisfaction. Research nurses assessed outcomes during home visits at 4, 13 and 26 weeks.
                Of the 250 participants (age 4 to 79 years), 240 were included in the analysis at 13 weeks (loss to follow-up 4%). Cure rates were 39% (95% confidence interval [CI] 29%-51%) in the cryotherapy group, 24% (95% CI 16%-35%) in the salicylic acid group and 16% (95% CI 9.5%-25%) in the wait-and-see group. Differences in effectiveness were most pronounced among participants with common warts (n = 116): cure rates were 49% (95% CI 34%-64%) in the cryotherapy group, 15% (95% CI 7%-30%) in the salicylic acid group and 8% (95% CI 3%-21%) in the wait-and-see group. Cure rates among the participants with plantar warts (n = 124) did not differ significantly between treatment groups.
                For common warts, cryotherapy was the most effective therapy in primary care. For plantar warts, we found no clinically relevant difference in effectiveness between cryotherapy, topical application of salicylic acid or a wait-and-see approach after 13 weeks. (ClinicalTrial.gov registration no. ISRCTN42730629). Actinic keratosis (AK) is a very common condition, which has the potential of progressing to squamous cell carcinoma. The present study is a prospective, randomized study comparing the lesion response, cosmetic outcome, patient satisfaction and tolerability of a new treatment modality, photodynamic therapy (PDT), using topical methyl aminolevulinate (Metvix), with the most commonly used standard therapy for AK, cryotherapy.
                A total of 204 patients with clinically diagnosed AK were randomized to either cryotherapy or PDT. The PDT patients were further assigned to an active or placebo group in a random, double-blind manner. Cryotherapy was performed using liquid nitrogen spray in a single freeze-thaw cycle. PDT was performed using 160 mg/g methyl aminolevulinate cream or placebo, a 3-hour application time, red light (570-670 nm) and a total light dose of 75 J/cm(2). PDT was repeated after 7 days. Two sessions of PDT were undertaken, as a previous study had shown a single session had similar efficacy to cryotherapy. Lesion response was assessed clinically after 3 months (complete response or non-complete response).
                The lesion response rate was 91% in the methyl aminolevulinate PDT group, 68% in the cryotherapy group and 30% in the placebo PDT group. Methyl aminolevulinate PDT was statistically significantly better than both cryotherapy and placebo PDT in terms of response rates and cosmetic outcome. Most patients preferred PDT to other treatments.
                PDT with methyl aminolevulinate is an excellent treatment option, particularly for patients with widespread damage or AK lesions in cosmetically sensitive areas. Four-hundred consecutive referrals with viral warts of the hands and/or feet were investigated to determine the cure rate from a combination of cryotherapy, keratolytic wart paint and paring. For treatment failures after 3 months, the value of continuing cryotherapy and of additional treatment with the immunomodulator inosine pranobex were assessed. Subjects were treated for 3 months with wart paint and cryotherapy and were randomized to receive, or not, paring in addition. Those who did not respond by 3 months were randomized to receive, or not, 3 months further cryotherapy, and to receive inosine pranobex 60 mg/kg/day for 1 week each month, or matching placebo. Fifty-two per cent of subjects were cured by 3 months. The chance of cure was inversely related both to the length of history and to the diameter of the largest wart. Paring improved the cure rate for plantar warts but not for hand warts. During the second 3 months the cure rate fell to 41%. Neither cryotherapy nor inosine pranobex significantly improved this response. Pulse dye laser (PDL) appears an attractive method to treat warts. However, data concerning the efficacy of this approach are based chiefly upon open clinical studies or case reports and results vary widely from one study to another. The purpose of this study was to compare the efficacy and safety of PDL with a placebo in the treatment of a homogeneous group of patients presenting palmoplantar warts.
                This was a randomized, prospective, placebo-controlled, single-blind study conducted between December 2004 and July 2005 in patients consulting for palmoplantar warts at the Dermatology Department of the University Teaching Hospital of Nice. The treatment settings used for the 595-nm PDL were as follows: spot diameter 5 mm, pulse duration 0.45 ms, fluence 9 J/cm2 with 5 passes at a frequency of 1 Hz. Cryogen spray cooling (system incorporated in the machine) was given at a rate of 50 spurts of 40 ms prior to each laser pulse. In patients in the placebo group, cooling pulses alone were given. For the plantar warts (in both groups), hyperkeratosis was removed manually with a scalpel before each session. A maximum of three sessions was administered at 3-week intervals. The type and number of warts was counted and recorded in a treatment schedule before the start of therapy, at each session and 5 weeks after the final session. The global safety of the treatment was evaluated using a visual analog scale between 0 (intolerable) and 10 (completely safe).
                Nineteen patients were included in the laser group and 16 were included in the placebo group. Sixty-four per cent (48/75) of warts in the laser group resolved completely compared with 13% (4/30) in the placebo group (p<0.001). In the PDL group, 6 of 19 patients (31.5%) no longer had warts by the end of the study compared with 3 of 16 patients (18.75%) in the placebo group (p=0.46). The global safety score of the treatment as assessed by the patients themselves was 8.31 in the laser group and 9.81 in the placebo group.
                Pulse dye laser appears to be an effective treatment in palmoplantar warts but the efficacy of this method seems to be only equivalent to that of standard treatments (cryotherapy or salicylic acid preparations). Safety is excellent and constitutes one of the major advantages of this technique. The absence of any proven superiority over the standard treatments in terms of efficacy, coupled with the high costs involved, means that PDL should only be used second-line therapy in patients wishing to avoid constraints affecting their professional activity. A study of open, randomized, parallel-group design was performed to investigate the impact of a second freeze-thaw cycle on the cure rate, at 3 months, from cryotherapy of common warts on the hands and feet. Cryotherapy was performed at 3-week intervals, and subjects were randomized to receive either one or two freeze-thaw cycles. In addition, all subjects used keratolytic wart paints throughout the study, and plantar warts were pared prior to freezing. Three hundred subjects were recruited. At 3 months, 124 were cured, 83 were not cured, and 93 had defaulted. Among those who did not default the cure rate was 57% from the single freeze technique, and 62% from the double freeze technique, a difference of 5% (P = 0.53, 95% CI-8.1-18.6). Separate analyses for subjects with warts on the hands and on the feet demonstrated no effect of double freezing on hand warts. In contrast, for plantar warts, the cure rate was 41% from single freezing and 65% for double freezing, a difference of 24% (P = 0.04, 95% CI 2.9-44.4). The use of a double freeze-thaw cycle confers little or no advantage over a single freeze in the treatment of hand warts, but may be considerably more effective for plantar warts. To determine the efficacy of duct tape compared with placebo in the treatment of verruca vulgaris.
                A randomized placebo-controlled trial in 3 primary schools in Maastricht, the Netherlands.
                One hundred three children aged 4 to 12 years with verruca vulgaris.
                Duct tape applied to the wart or placebo, a corn pad (protection ring for clavi), applied around the wart for 1 night a week. Both treatments were applied for a period of 6 weeks. Patients were blinded to the hypothesis of the study.
                Complete resolution of the treated wart.
                After 6 weeks, the wart had disappeared in 16% of the children in the duct tape group compared with 6% in the placebo group (P = .12). The estimated effect of duct tape compared with placebo on diameter reduction of the treated wart was 1.0 mm (P = .02, 95% confidence interval, -1.7 to -0.1). After 6 weeks, in 7 children (21%) in the duct tape group, a surrounding wart had disappeared compared with 9 children (27%) in the placebo group (P = .79). Fifteen percent of the children in the duct tape group reported adverse effects such as erythema, eczema, and wounds compared with 0 in the placebo group (P = .14).
                In a 6-week trial, duct tape had a modest but nonsignificant effect on wart resolution and diameter reduction when compared with placebo in a cohort of primary school children. The common wart is a common infectious disease caused by human papilloma virus. A variety of therapeutic modalities are available. Cryotherapy (liquid nitrogen) is one of the most common treatment forms. It freezes the tissue and destroys warts. Phenol is a caustic agent. Our purpose was to evaluate and compare the efficacy of cryotherapy and 80 percent phenol solution on common warts of hands.
                This single-blinded clinical trial study was performed on 60 patients with common warts referred to the dermatology clinic of Ghaem Hospital Mashhad, Iran, in 2002. Patients were randomly divided into two groups; 30 patients were treated with cryotherapy and 30 patients were treated with 80 percent phenol, on a once-weekly basis until complete clearance of the lesions or a maximum duration of six weeks.
                Complete clearance of warts after six weeks was observed in 70 percent of patients who were treated with cryotherapy, and 82.6 percent of patients in the 80 percent phenol group; there was no statistically significant difference between the two methods (p-value is 0.014).
                Our data indicates that 80 percent phenol and cryotherapy are effective and simple treatments for common warts of hands, and patients do not experience any pain during the treatment. Actinic keratosis (AK), the most common premalignant skin condition, can represent a management challenge. Treatment should not only be effective, but also well tolerated and allow for good cosmesis on typical sun-exposed highly visible body sites.
                The primary objective was to compare the lesion response and subject preference for topical methyl aminolaevulinate (MAL)-photodynamic therapy (PDT) vs. cryotherapy for the treatment of AK.
                In this 24-week, multicentre, randomized, intraindividual (right-left) study, subjects received both one treatment session of MAL-PDT and a double freeze-thaw cryotherapy; the treatments were randomly allocated to either side of the face/scalp. Lesions with a noncomplete response were retreated after 12 weeks. The primary assessments were the subject's overall preference and lesion response at week 24. Secondary assessments included lesion response at week 12, cosmetic outcome, subject and investigator cosmetic outcome preference at week 24, and investigator overall preference at week 24. Skin discomfort and adverse events were also evaluated.
                In total, 119 subjects with 1,501 lesions were included in the study. At week 12, treatment with MAL-PDT resulted in a significantly larger rate of cured lesions relative to cryotherapy (percentage lesion reduction from baseline: 86.9% vs. 76.2%; P < 0.001). At week 24, both treatment groups showed a high rate of cured lesions (89.1% for MAL-PDT vs. 86.1% for cryotherapy; P = 0.20; 95% confidence interval: -1.62 to 7.67). Results for subject and investigator preferences as well as cosmetic outcome favoured MAL-PDT. Both treatment regimens were safe and well tolerated.
                The present study shows that, when treated with both MAL-PDT and cryotherapy, subjects significantly prefer MAL-PDT treatment for AK. MAL-PDT is an attractive treatment option for AK, with comparable efficacy and superior cosmetic outcomes compared with double freeze-thaw cryotherapy. Common warts (verrucae vulgares) are human papilloma virus (HPV) infections with a high incidence and prevalence, most often affecting hands and feet, being able to impair quality of life. About 30 different therapeutic regimens described in literature reveal a lack of a single striking strategy. Recent publications showed positive results of photodynamic therapy (PDT) with 5-aminolevulinic acid (5-ALA) in the treatment of HPV-induced skin diseases, especially warts, using visible light (VIS) to stimulate an absorption band of endogenously formed protoporphyrin IX. Additional experiences adding waterfiltered infrared A (wIRA) during 5-ALA-PDT revealed positive effects.
                First prospective randomised controlled blind study including PDT and wIRA in the treatment of recalcitrant common hand and foot warts. Comparison of "5-ALA cream (ALA) vs. placebo cream (PLC)" and "irradiation with visible light and wIRA (VIS+wIRA) vs. irradiation with visible light alone (VIS)".
                Pre-treatment with keratolysis (salicylic acid) and curettage. PDT treatment: topical application of 5-ALA (Medac) in "unguentum emulsificans aquosum" vs. placebo; irradiation: combination of VIS and a large amount of wIRA (Hydrosun) radiator type 501, 4 mm water cuvette, waterfiltered spectrum 590-1400 nm, contact-free, typically painless) vs. VIS alone. Post-treatment with retinoic acid ointment. One to three therapy cycles every 3 weeks. Main variable of interest: "Percent change of total wart area of each patient over the time" (18 weeks). Global judgement by patient and by physician and subjective rating of feeling/pain (visual analogue scales). 80 patients with therapy-resistant common hand and foot warts were assigned randomly into one of the four therapy groups with comparable numbers of warts at comparable sites in all groups.
                The individual total wart area decreased during 18 weeks in group 1 (ALA+VIS+wIRA) and in group 2 (PLC+VIS+wIRA) significantly more than in both groups without wIRA (group 3 (ALA+VIS) and 4 (PLC+VIS)): medians and interquartile ranges: -94% (-100%/-84%) vs. -99% (-100%/-71%) vs. -47% (-75%/0%) vs. -73% (-92%/-27%). After 18 weeks the two groups with wIRA differed remarkably from the two groups without wIRA: 42% vs. 7% completely cured patients; 72% vs. 34% vanished warts. Global judgement by patient and by physician and subjective rating of feeling was much better in the two groups with wIRA than in the two groups without wIRA.
                The above described complete treatment scheme of hand and foot warts (keratolysis, curettage, PDT treatment, irradiation with VIS+wIRA, retinoic acid ointment; three therapy cycles every 3 weeks) proved to be effective. Within this treatment scheme wIRA as non-invasive and painless treatment modality revealed to be an important, effective factor, while photodynamic therapy with 5-ALA in the described form did not contribute recognisably - neither alone (without wIRA) nor in combination with wIRA - to a clinical improvement. For future treatment of warts an even improved scheme is proposed: one treatment cycle (keratolysis, curettage, wIRA, without PDT) once a week for six to nine weeks. In spite of many available studies on bleomycin and cryotherapy in treating warts, little head to head research is done to compare efficacy of these treatments. Our aim was to compare the therapeutic effects of intralesional bleomycin and cryotherapy on common warts of the hands and feet. In this clinical trial 44 patients above 12 years of age referred to the dermatology clinic of Bouali University Hospital were enrolled. The patients were required to have warts on at least two symmetric limbs (hands or feet). The warts located on right and left limbs of each patient were examined and counted. Each patient received both cryotherapy and intralesional bleomycin on his or her warts. The two treatment types were randomly allocated to either right sided or left sided warts. Each patient was evaluated at 2 week intervals and retreated if necessary up to three times. Data were analyzed by SPSS 11 and EPI Info 2002 statistical packages. The mean number of warts was 5.2 on upper limbs and 4.6 on lower limbs. In 86.4 percent of the cases all warts on the limb side treated by intralesional bleomycin were cleared compared with 68.2 % for cryotherapy (P<0.05). Relative risk for the effect of bleomycin compared to cryotherapy in this regard was 1.27 (1<RR<1.6). We found bleomycin to have a clearance rate equal to 87.6 percent of warts, compared to 72.3 percent by cryotherapy. Relative risk for therapeutic effect of bleomycin compared to cryotherapy in this regard was 1.23 (1.11<RR<1.33). Conclusion: Intralesional bleomycin is more effective than cryotherapy in treating warts on hands and feet. A series of eleven comparative wart treatment trials undertaken between 1969 and 1975 and involving 1802 patients is described. A method of coding provided groups of patients matched for age, type, number and duration of warts, within which treatments could be randomized. The variation in response to treatment was shown to be influenced significantly by these factors and the level of cure to depend on the proportions of the various response groups within the population under consideration. These proportions were found to vary geographically and at different periods. In all the trials the results were assessed at 12 weeks. In the treatment of hand warts, the percentage cure of patients treated with liquid nitrogen fell significantly from 75 to 40% when the interval between freezings was increased from 3 to 4 weeks. The average number of freezings required for a cure was 3-1 amongst all patients cured by 6 or less freezings at intervals of 2 or 3 weeks. In a two-centre trial there was no significant difference between the percentage cure of patients with hand warts treated with liquid nitrogen (69%) and of those applying a paint containing salicylic and lactic acids (SAL) (67%). Patients receiving both treatments concurrently did better (78%) but the difference was not found to be statistically significant. In the treatment of simple plantar warts the percentage cure for the SAL paint (84%) was found to compare favourably with that for a podophyllin treatment (81%). Only one of the patients cured by the paint in that trial was found to have had a recurrence after 6 months. The paint was found to be satisfactory for use under general practice conditions. Additions to the formula did not alter its effectiveness. In the treatment of mosaic plantar warts the overall percentage cure for the SAL paint in a series of comparative trials (1969-75) was 45%. In these trials it was compared directly with one or more other preparations. No differences were found between its efficacy and that of 10% buffered gluteraldehyde (47%), 40% benzalkonium chloride dibromide (Callusolve 40) (30%) and 5% 5-fluorouracil in dimethyl sulphoxide (53%). Only 25% of thirty-six patients treated with 5% idoxuridine in dimethylsulphoxide were cured. Throughout the trials approximately 30% of patients with hand warts, 20% of those with simple plantar warts and 50% of those with mosaic plantar warts were found to be resistant to treatment. The adoption of treatment with SAL paint for hand warts and simple plantar warts by the general practitioners in the Edinburgh area has proved satisfactory. Only resistant cases are now referred to hospital and these can be treated within a few weeks instead of 4-5 months as was the case in 1969. To compare the clinical effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts.
                A multicentre, open, two arm randomised controlled trial.
                University podiatry school clinics, NHS podiatry clinics, and primary care in England, Scotland, and Ireland.
                240 patients aged 12 years and over, with a plantar wart that in the opinion of the healthcare professional was suitable for treatment with both cryotherapy and salicylic acid.
                Cryotherapy with liquid nitrogen delivered by a healthcare professional, up to four treatments two to three weeks apart. Patient self treatment with 50% salicylic acid (Verrugon) daily up to a maximum of eight weeks.
                Complete clearance of all plantar warts at 12 weeks. Secondary outcomes were (a) complete clearance of all plantar warts at 12 weeks controlling for age, whether the wart had been treated previously, and type of wart, (b) patient self reported clearance of plantar warts at six months, (c) time to clearance of plantar wart, (d) number of plantar warts at 12 weeks, and (e) patient satisfaction with the treatment.
                There was no evidence of a difference between the salicylic acid and cryotherapy groups in the proportions of participants with complete clearance of all plantar warts at 12 weeks (17/119 (14%) v 15/110 (14%), difference 0.65% (95% CI -8.33 to 9.63), P=0.89). The results did not change when the analysis was repeated but with adjustment for age, whether the wart had been treated previously, and type of plantar wart or for patients' preferences at baseline. There was no evidence of a difference between the salicylic acid and cryotherapy groups in self reported clearance of plantar warts at six months (29/95 (31%) v 33/98 (34%), difference -3.15% (-16.31 to 10.02), P=0.64) or in time to clearance (hazard ratio 0.80 (95% CI 0.51 to 1.25), P=0.33). There was also no evidence of a difference in the number of plantar warts at 12 weeks (incident rate ratio 1.08 (0.81 to 1.43), P=0.62).
                Salicylic acid and the cryotherapy were equally effective for clearance of plantar warts.
                Current Controlled Trials ISRCTN18994246, National Research Register N0484189151. Actinic keratoses (AKs) are the most common premalignant tumors. Without treatment, a significant number of patients with AK will experience squamous cell carcinoma. Photodynamic therapy (PDT) using the new highly selective photosensitizer methyl 5-aminolevulinate is a promising new treatment modality for AK.
                We investigated the complete response rates, cosmetic outcome, and patient satisfaction after photodynamic therapy (PDT) using methyl 5-aminolevulinate (Metvix) versus cryotherapy in the treatment of AKs.
                Patients were randomized to receive either cryotherapy with liquid nitrogen spray or PDT using methyl 5-aminolevulinate cream 160 mg/g, 3 hours application time, and red light (75 J/cm(2)).
                Efficacy results from 193 patients with 699 lesions (92% face/scalp and 93% thin/moderately thick) were analyzed. Overall complete response rates after 3 months were 69% for PDT and 75% for cryotherapy. Both treatments gave higher response rates in thin lesions (PDT 75%, cryotherapy 80%). PDT gave better cosmetic results and higher patient satisfaction than cryotherapy.
                PDT using methyl 5-aminolevulinate is an attractive treatment option for patients with AK, with a response rate similar to that of cryotherapy, but with superior cosmetic results and high patient satisfaction. To evaluate the efficacy of duct tape occlusion therapy for the treatment of common warts in adults.
                Double-blind controlled clinical intervention trial.
                Veterans Affairs medical center.
                A total of 90 immunocompetent adult volunteers with at least 1 wart measuring 2 to 15 mm were enrolled between October 1, 2004, and July 31, 2005. Eighty patients completed the study.
                Patients were randomized by a computer-generated code to receive pads consisting of either moleskin with transparent duct tape (treatment group) or moleskin alone (control group). Patients were instructed to wear the pads for 7 consecutive days and leave the pad off on the seventh evening. This process was repeated for 2 months or until the wart resolved, whichever occurred first. Follow-up visits occurred at 1 and 2 months.
                Complete resolution of the target wart. Secondary outcomes included change in size of the target wart and recurrence rates at 6 months for warts with complete resolution.
                There were no statistically significant differences in the proportions of patients with resolution of the target wart (8 [21%] of 39 patients in the treatment group vs 9 [22%] of 41 in the control group). Of patients with complete resolution, 6 (75%) in the treatment group and 3 (33%) in the control group had recurrence of the target wart by the sixth month.
                We found no statistically significant difference between duct tape and moleskin for the treatment of warts in an adult population. To determine the effect of facial skin resurfacing for treatment of actinic keratoses (AKs) and prophylaxis against new primary basal and squamous cell carcinomas in individuals with previous nonmelanoma skin cancer (NMSC) or severe photodamage.
                Randomized, prospective 5-year trial.
                Dermatology and otolaryngology clinics of a Veterans Affairs hospital.
                Thirty-four patients with a history of facial or scalp AKs or basal or squamous cell carcinoma were enrolled. Five of 7 eligible patients who declined study-related treatment were used as controls. Twenty-seven patients were randomized to 3 treatment arms; 3 patients were discontinued from the study.
                Carbon dioxide laser resurfacing, 30% trichloroacetic acid peel, or 5% fluorouracil cream applied twice daily for 3 weeks.
                Reduction in the number of AKs was measured 3 months after treatment. The incidence of new NMSC in treated areas was assessed between January 1, 2001, and June 30, 2005. Times from baseline to diagnosis of first skin cancer were compared between the treatment and control groups.
                Treatment with fluorouracil, trichloroacetic acid, or carbon dioxide laser resulted in an 83% to 92% reduction in AKs (P< or =.03), a lower incidence of NMSC compared with the control group (P<.001), and a trend toward longer time to development of new skin cancer compared with the control group (P=.07). However, no significant differences were noted among the treatment groups.
                All 3 modalities demonstrated benefit for AK reduction and skin cancer prophylaxis compared with controls and warrant further study in a larger trial. Pulsed dye laser (PDL) in conjunction with cryogen spray cooling (CSC) is effective in improving efficacy and safety for treatment of port wine stains (PWSs) in whites. However, for dark-skinned patients such as Chinese, only retrospective studies have been performed.
                To compare prospectively clinical efficacy in terms of blanching and acute and long-term adverse effects of PDL alone and PDL-CSC for treatment of PWSs in Chinese patients.
                Thirty-five Chinese patients (13 males and 22 females) were recruited, and 131 treatments were performed. Half of the test area on the PWS was treated with PDL alone, and the contralateral half was treated with PDL-CSC. The degree of PWS blanching was objectively assessed by spectrophotometer. Skin textural changes were detected by cutometer. All measurements were taken at baseline and before each subsequent laser treatment. Patients were interviewed immediately after treatment and again the following week using a visual analog scale questionnaire to assess the degree of pain and swelling. Occurrence of blisters was noted during each follow-up visit. Patients were evaluated for evidence of long-term adverse effects such as dyspigmentation and scarring after three treatments.
                Statistically significant higher fluences were used on the PDL-CSC-treated group. The percentage change in the spectrophotometer a* value was significantly greater using PDL-CSC, indicating that there was more PWS blanching after treatment. There was no significant difference in the incidence of skin textural changes after three treatments with PDL alone or PDL-CSC. The immediate pain scores were significantly higher for PDL alone than with PDL-CSC. Blisters were significantly more common on the area treated using PDL alone than PDL-CSC. The overall incidence of long-term adverse effects was not significantly different between the PDL alone and PDL-CSC treatments. PDL-CSC was also the preferred treatment modality for most patients.
                PDL-CSC was more effective than PDL alone for blanching of PWS in Chinese patients. Moreover, PDL-CSC was better tolerated and resulted in a lower incidence of acute adverse effects such as blistering. Foamed sclerosing agents have been used with enthusiasm by phlebologists for more than 5 decades. Any type of varicose veins can and has been treated with this technique. Numerous publications have stressed the advantages of foamed sclerosing agents on the basis of empiric and experimental criteria and have described various individual techniques to prepare foams. Until now, however, no comparative study for the treatment of large varicose veins with foam or liquid exists.
                The purpose of this first randomized, prospective, multicenter trial was to study the elimination of reflux, the rate of recanalization, and possible side effects of foam sclerotherapy (FS) compared with conventional liquid sclerotherapy for the greater saphenous vein (GSV).
                Eighty-eight patients were randomized into two groups: One group was treated with sclerosing foam (45 patients) and the other with sclerosing liquid (43 cases). Sclerotherapy was performed with direct puncture of the vessel under duplex guidance. The reference sclerosing agent was polidocanol in a 3% solution. The foam was prepared using the Double Syringe System (DSS) method. Only one injection of 2.0 or 2.5 mL liquid or foam was allowed, depending on the diameter of the GSV. Results were assessed according to the protocol.
                Follow-up after 3 weeks showed 84% elimination of reflux in the GSV with DSS foam versus 40% with liquid sclerosant (P < 0.01). At 6 months, six recanalizations were found in the liquid group versus two in the foam group. After 1 year, no additional recanalization was observed with either foam or liquid. Longer term studies are underway. Side effects did not differ between both groups.
                The efficacy of sclerosing foam (DSS) compared with sclerosing liquid in therapy of the GSV is superior, a finding that had already gained empirical recognition but for which there has not been any clinical evidence to date. Radiation therapy is an important curative modality in the treatment of patients with head and neck cancer. However, radiation-induced changes in the oral cavity, such as xerostomia and mucositis, are among the most debilitating treatment sequelae experienced by patients undergoing radiation therapy, and attempts at ameliorating these side effects have been poor at best. Pilocarpine has been approved for post-radiation xerostomia, and the effect of its use during radiation therapy on salivary flow, xerostomia, mucositis, and quality of life (QOL) was assessed in a phase III study conducted by the Radiation Therapy Oncology Group (RTOG 97-09). In total, 245 evaluable patients were randomized to pilocarpine or placebo. Selected patients were required to have > or = 50% of the volume of the major salivary glands receive > or = 50Gy; to agree to provide stimulated and unstimulated samples of saliva (measured in g) before treatment, at the end of treatment, and 3 and 6 months after completion of radiation therapy; and to complete the University of Washington Head and Neck Symptom Scale. Following the completion of radiation therapy, the average unstimulated salivary flow was statistically greater in the pilocarpine group, whereas no difference was noted following parotid stimulation. There was no effect on the amelioration of mucositis. The results of the QOL scales did not reveal any significant difference between the pilocarpine and placebo groups with regard to xerostomia and mucositis. The significant difference in unstimulated salivary flow supports the concomitant use of oral pilocarpine to decrease radiation-associated xerostomia. However, the absent correlation between improved salivary flow and QOL scores is of some concern (though not a new finding) and may be related to the existence of comorbidities and the lack of effect on mucositis. Recently, a randomised study demonstrated the utility of oral cooling (cryotherapy) in the prevention of 5-fluorouracil (5FU)-induced stomatitis. In order to verify these results a confirmatory study, using identical treatment regimen, was initiated. 84 patients treated with a 5-FU-containing regimen were randomised to a control arm or to receive oral cryotherapy. End point evaluation was obtained by a global assessment of the physician's judgement and patients' description of mucositis severity graded 0-4. Mucositis was significantly reduced by cryotherapy considering both the first cycle of therapy (the mean toxicity score for cryotherapy was 0.59 and it was 1.1 for the control group, P < or = 0.05) and all the chemotherapeutic courses (the mean toxicity score for cryotherapy was 0.36 when it was 0.69 for the control group, P < or = 0.05). In conclusion, the present study confirms that cryotherapy can decrease 5FU-induced stomatitis and should be recommended for patients receiving bolus 5FU-containing regimens. To compare the efficacy, tolerability, and cosmetic outcome of photodynamic therapy (PDT) using topical methyl aminolevulinate with cryotherapy or topical fluorouracil for treatment of squamous cell carcinoma in situ.
                Randomized, placebo-controlled study, with follow-up at 3 and 12 months after last treatment.
                Forty outpatient dermatology centers in 11 European countries.
                Random sample of 225 patients with histologically confirmed squamous cell carcinoma in situ (lesion size, 6-40 mm) and no evidence of progression.
                Treatment with PDT with methyl aminolevulinate (160 mg/g; n = 96) or matching placebo cream (n = 17), cryotherapy (n = 82), or topical fluorouracil (5% cream; n = 30). Methyl aminolevulinate or placebo cream was applied for 3 hours before illumination with broadband red light (75 J/cm2, 570-670 nm). Treatment was repeated 1 week later. Cryotherapy was performed with liquid nitrogen spray. Fluorouracil was applied for 4 weeks. Lesions with a partial response at 3 months were re-treated.
                Clinically verified complete response of lesions; blinded and on-site assessment of cosmetic outcome (4-point rating scale).
                At 12 months, the estimated sustained lesion complete response rate with methyl aminolevulinate PDT was superior to that with cryotherapy (80% vs 67%; odds ratio, 1.77; 95% confidence interval, 1.01-3.12; P = .047), and better than that with fluorouracil (80% vs 69%; odds ratio, 1.64; 95% confidence interval, 0.78-3.45; P = .19). Cosmetic outcome at 3 months was good or excellent in 94% of patients treated with methyl aminolevulinate PDT vs 66% with cryotherapy and 76% with fluorouracil, and was maintained at 12 months.
                Methyl aminolevulinate PDT is an effective treatment option for squamous cell carcinoma in situ, with excellent cosmesis. To compare the efficacy, tolerance and safety of two types of cryotherapy, performed by family physicians, for benign cutaneous lesions: low freezing (-59 degrees C) with dimethyl either-propane cryogenic spray (DMEP) and intense freezing (196 degrees C) with conventional liquid nitrogen (LN).
                A randomised, multi-centered, controlled clinical trial, with single-blind assessment.
                Three primary care teaching teams in the Community of Madrid.
                Ten MIR from family & community medicine intervened. There were 124 patients, who had 174 benign cutaneous lesions, suitable for cryotherapy. There were 3 voluntary withdrawals, none because of an adverse reaction. Interventions, in each case there was local application for a standard time of the randomised agent. Control-group intervention, 81 cases: swab soaked in LN. Study-group intervention, 93 cases: swab saturated with DMEP spray. Maximum of three freezings per case, at weekly intervals.
                A doctor made a blind assessment of the results (elimination, adverse reaction, aesthetic result) 15 days after treatment.
                No clinically relevant differences between the efficacy, tolerance and safety of the two cryogenic agents used in primary care were found. The low freezing of DMEP was sufficient for the cryotherapy of benign lesions. Photodynamic therapy (PDT) with topical 5-aminolaevulinic acid (ALA) followed by irradiation with incoherent light (ALA-PDT) for recalcitrant warts have had beneficial results. Therefore, we undertook a randomised, parallel, double-blind clinical trial of ALA-PDT versus placeboPDT for recalcitrant foot and hand warts.
                Recalcitrant foot and hand warts were randomly assigned to six repetitive ALA-PDT or placebo-PDT interventions combined with standard treatment encompassing paring followed by a keratolytic (Verucid). Standardised photographs of each wart were taken before, during (week 7) and after treatment (weeks 14 and 18). The area of each wart compared with entry area was the primary outcome variable, measured from photographs by an evaluator unaware of treatment allocation for intervention. Pain intensity immediately and 24 h after each intervention was assessed by a five-point scale.
                A total of 232 foot and hand warts in 45 patients were entered into the trial: 117 warts were allocated to ALA-PDT and 115 warts to placebo-PDT. In week 14, the median relative reduction in wart area was 98% in the ALA-PDT group (interquartile range 100%, 55%) versus 52% (100%, 0) in the placebo group (p=0.0006). In week 18, the median relative reduction in wart area was 100% in the ALA-PDT group (100%, 57%) versus 71% (100%, 0) in the placebo-PDT arm (p=0.008). Both the number of vanishing warts and the difference in relative wart area of persisting warts at week 14 and 18 were significant (p<0.05) in favour of ALA-PDT. Significantly more ALA-PDT warts were graded at a higher pain intensity after treatment than placebo-PDT warts.
                ALA-PDT is superior to placebo-PDT when both wart area and number of vanishing warts are considered. In the conservative therapy of venous leg ulcers modern types of dressings are used most frequently. In the past 20 years 'active wound dressings' - cultured epidermal keratinocytes as autografts and allografts - were also introduced in the management of leg ulcers.
                The aim of our study was to compare the effect of cryopreserved and lyophilized cultured epidermal allografts in the treatment of venous leg ulcers. Evaluation of the therapy was documented as photodocumentation, planimetry, healing time and evaluation of pain relief over a 3-month period after application. Fifty patients with venous leg ulcers were selected. Twenty-five patients (group I) were treated with cryopreserved keratinocytes and 25 (group II) with lyophilized keratinocytes.
                The final evaluation 3 months after the application of allografts showed 84% of healed ulcers in group I and 80% in group II. The number of healed ulcers and the healing rate both showed no statistically significant differences. The size of the ulcer was reduced by half during the first week in both groups. The size differences during the first week are statistically significant in both groups and they are comparable (P < 0.001). The intensity of the pain was statistically significantly reduced during the first week after application in both groups (P < 0.001).
                The cryopreserved and lyophilized cultured allografts are comparable in healing rate, course of healing and relief of pain, and also in planimetric changes during the healing of venous leg ulcers. Lyophilized allografts are more convenient for routine use than cryopreserved allografts as they can be stored at room temperature. These results could give rise to the more frequent use of lyophilized allografts in slow-healing venous leg ulcers. Cryotherapy is the standard of care for clinically apparent (target) actinic keratoses (AKs). Topical imiquimod may reduce initially inapparent or subclinical AKs.
                We evaluated the potential of topical imiquimod to decrease subclinical AKs after cryotherapy of target AKs.
                A randomized trial of imiquimod or vehicle twice weekly for 8 weeks following 3- to 5-second cryotherapy of target AKs within a 50 cm(2) field at the face or scalp was conducted. Efficacy outcomes included clearance of target, subclinical, and total AKs and proportions clear of AKs. Subjects with residual AKs were offered cryotherapy and open-label imiquimod twice weekly for 8 weeks.
                Sixty-three subjects completed the randomized phase. At 12 weeks, target AK clearance was similar for imiquimod and vehicle (79% vs 76%), but fewer total AKs were noted for imiquimod (78 vs 116). This was due to a progressive reduction in subclinical AKs with imiquimod compared with a progressive increase with vehicle. More subjects treated with imiquimod achieved clearance of subclinical (58% vs 34%; p = .06) and total (23% vs 9%; p = .21) AKs.
                Imiquimod postcryotherapy may increase clearance of subclinical and total AKs and proportions of subjects clear at 3 months. These findings require confirmation in larger controlled trials powered for statistical significance. The authors previously reported that 30 minutes of oral cryotherapy inhibits 5-fluorouracil (5-FU)-induced stomatitis. The current trial was designed to determine whether a longer duration of cryotherapy would provide additional protection.
                This trial involved patients who were receiving their first course of a 5-FU plus leucovorin chemotherapy regimen, for which stomatitis is a major dose-limiting toxicity. These patients were randomized to receive either 30 or 60 minutes of oral cryotherapy given at around the same time as the 5-FU therapy.
                A total of 178 evaluable patients were studied. Both cryotherapy groups had similar degrees of mucositis.
                The authors continue to recommend the use of 30 minutes of oral cryotherapy for patients receiving bolus intensive courses of 5-FU-based chemotherapy. Though not in regular practice, intralesional (IL) bleomycin has been used for the treatment of warts since the 1970s and on the other hand, till now cryotherapy is quite regularly used to treat warts. Aim: Our aim was to assess the evidence for the efficacy of IL bleomycin, in comparison with a control group of similar sample receiving cryotherapy, in the treatment of cutaneous warts.
                Patients were randomized using computer-generated codes to receive either cryotherapy (double freeze-thaw cycle) or IL bleomycin (0.1% solution with concurrent anesthesia) for a maximum of four treatments 3 weeks apart and a maximum of five warts treated in each visit for both groups. Patients had their warts measured at base-line and with each return visit including a post treatment follow-up that was 8 weeks apart from last treatment taken.
                Of the 73 patients completing the study, 39 (53%) were treated with IL bleomycin and 34 (47%) were treated with cryotherapy. Out of 155 treated warts, 87 (56%) were treated with IL beomycin and 68 (44%) were treated with cryotherapy. The clearance rates in context of number of patients and number of warts were 94.9% and 97% for bleomycin and 76.5% and 82% for cryotherapy respectively (P < 0.05 by x(2) analysis and RR = 7.67).
                IL bleomycin injection was significantly more effective than cryotherapy for treatment of cutaneous wart. Subjects with warts on their hands and/or feet were randomly assigned to a hypnotic suggestion, topical salicylic acid, placebo, or no treatment control condition. Subjects in the three treated groups developed equivalent expectations of treatment success. Nevertheless, at the six-week follow-up interval only the hypnotic subjects had lost significantly more warts than the no treatment controls. Theoretical implications are discussed. A randomized study was performed to compare efficacy and side effects of laser and cryotherapy: 51 patients were treated with laser vaporization and 50 patients with cryotherapy. Success rates for laser and cryotherapy were not significantly different. Success rates were significantly related to lesion size. Grade of CIN, positive endocervical curettage, parity, and age at treatment were not found to be related. Vaginal discharge, both in duration and amount, was significantly less in patients treated with laser vaporization, compared with cryotherapy, but pain and bleeding occurred more often in patients treated with laser vaporization. A brief review of possible sources of bias in comparative studies on laser and cryotherapy is given, indicating the preference for a randomized study. It is concluded that widespread introduction of laser facilities in smaller centers is not justified, because the success rates are not better than those of cryotherapy, and because the advantages of less discharge are outweighed by the high cost. The efficacy of sclerosing agents for the treatment of telangiectasias and reticular veins is well established. The injection of these agents is often associated with pain, and it is not uncommon for sclerotherapists to include lidocaine with the sclerosants in an attempt to reduce the pain associated with treatment. However, there are concerns that this may reduce the overall efficacy of the treatment because of dilution of the sclerosant. Patient comfort and overall outcome associated with treatment using HS with lidocaine (LIDO) versus that using HS alone was compared.
                Forty-two patients were prospectively entered into the study and randomized blindly to sclerotherapy with 23.4% HS or 19% LIDO. Study subjects and treating physicians were blinded to the injection solution used. Injection sites were chosen for veins ranging in size from 0.1 to 3 mm. Photographs of the area to be treated were taken, and the patients rated their pain. They were then observed at regular intervals for four months, and clinical data was collected. Thirty-five subjects completed the full follow-up period, and photographs of the injected area were taken again. Three investigators blinded to the treatment assignment then evaluated the photographs and scored the treatment efficacy according to a standardized system.
                In the HS group, 61.9% (13 of 21) patients rated their pain as none or mild, whereas 90.5% (19 of 21) of patients in the LIDO group had no or mild discomfort. This difference is significant, with a P value of.034. There was no difference in the overall efficacy of treatment between the two groups. The groups had similar rates of vein thrombosis and skin necrosis.
                Although lidocaine is often used with sclerosing agents, there are no previous reports in the literature to evaluate its effectiveness in reducing the pain experienced by the patient. In this study, patients receiving LIDO experienced significantly less discomfort at the time of injection than patients who received HS alone. There were no differences in the effectiveness of treatment or in the incidence of complications between the two groups. We studied the efficacy, and time to clearance, of more frequent cryotherapy of viral warts, by randomizing 225 patients to receive treatment at 1-, 2- or 3-weekly intervals. The mean times to clearance of warts in each group were 5.5, 9.5 and 15 weeks in the weekly, 2-weekly and 3-weekly groups, respectively (P < 0.01). Cure rates after 3 months correlated with frequency of treatment (P < 0.05). After 3 months, 43% (66% of non-defaulters) had cleared in the group treated weekly, 37% (47%) of the group treated every 2 weeks, and 26% (30%) of those treated every 3 weeks. The mean numbers of treatments needed to achieve clearance were similar in each group (5.5, 4.75 and 5 treatments). After 12 treatments, cure rates were similar for all three groups: 43% for the weekly-treated group (3 months), 48% for the 2-weekly group (6 months), and 44% for the 3-weekly group (9 months). Percentage cure is related to the number of treatments received, and independent of the interval between treatments. A more rapid cure may, therefore, be achieved by more frequent treatment. The efficacy and suitability of photodynamic therapy (PDT) was compared with that of cryotherapy in the treatment of 40 lesions of Bowen's disease. Lesions were randomized to receive either cryotherapy with liquid nitrogen, or PDT using a portable desktop lamp incorporating a 300 W xenon short arc discharge source. A porphyrin precursor, 5-aminolaevulinic acid (5-ALA), was applied topically 4 h before irradiation in the PDT group. Each lesion received 125 J/cm2 at a fluence rate of 70 mW/cm2. All patients were reviewed at 2-monthly intervals and treatments repeated if required. Cryotherapy produced clearance in 10 of 20 lesions after one treatment, the remaining 10 lesions requiring two or three treatment applications. PDT resulted in clearance of 15 of 20 lesions after one treatment and of the remaining five lesions after a second treatment. The probability that a lesion cleared after one treatment was greater with PDT than cryotherapy (P < 0.01). Cryotherapy was associated with ulceration (five of 20), infection (two of 20) and recurrent disease (two of 20); no such complications occurred following PDT. PDT using a non-laser light source and topical 5-ALA appears to be at least as effective as cryotherapy in the treatment of Bowen's disease with fewer adverse effects. The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer.
                Patients with previously untreated GI cancer receiving bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC-grading) and duration of OM.
                Among 225 patients randomized, 206 answered the questionnaire (70, 64, and 63 patients in Arms A, B, and C, respectively) and were well balanced with respect to diagnoses, stage, age, sex, smoking habits, and performance status. Mucositis grade 3-4 occurred more frequently in Arm B (33%) than in A (13%, P< .01) and C (11%, P< .005). Duration was significantly longer in B than in both A (P= .035) and C (P= .003).
                The frequency and duration of OM are significantly improved by prophylactic chlorhexidine and by cryotherapy. The latter is easy and inexpensive but has limited use, as it is drug- and schedule-dependent. The current study is the first double-blind randomized evaluation of prophylactic chlorhexidine in a large adult patient population with solid tumors receiving highly OM-inducing chemotherapy. A role for chlorhexidine in the prevention of OM is suggested, which should be evaluated further. Photodynamic therapy (PDT) is increasingly used for treatment of actinic keratoses (AKs) but is a cumbersome procedure. A thin self-adhesive patch (PD P 506 A) containing 5-aminolaevulinic acid (5-ALA) was developed to facilitate PDT.
                To investigate efficacy and safety of the patch in comparison with placebo-PDT (superiority design, observer-blinded; study AK 03) and standard therapy, cryosurgery (noninferiority design, open; study AK 04).
                Two separate confirmatory randomized parallel-group phase III studies were set up. In total, 449 patients with up to eight mild to moderate AK study lesions located on the head were treated in 29 German study centres (study AK 03: 103 patients; study AK 04: 346 patients).
                Twelve weeks after treatment, 5-ALA patch-PDT proved to be superior to placebo-PDT (P < 0.001) and cryosurgery (P = 0.007). Efficacy rates on a lesion basis were 82% (AK 03) and 89% (AK 04) for PDT, 77% for cryosurgery and 19% (AK 03) and 29% (AK 04) for placebo-PDT. Local reactions at the treatment site occurred in almost all patients treated with 5-ALA patch-PDT or cryosurgery. Headache was the only side-effect not related to the treatment site which occurred in more than one patient.
                PD P 506 A is an innovative, easy-to-handle 5-ALA patch for PDT of mild to moderate AK lesions. Compared with current PDT procedures, pretreatment (e.g. curettage) is not needed and handling is considerably facilitated. A single PDT treatment results in efficacy rates being statistically significantly superior to placebo and cryosurgery. To observe the therapeutic effect of shenqi fanghou recipe (SFR) in preventing and treating radiation injury in patients with head and neck tumor.
                One hundred and forty patients with head and neck tumor, including nasopharyngeal carcinoma, carcinoma of tonsil or tongue, were randomly divided into 2 groups, 70 patients in the observed group were given modified SFR as adjuvant to radiotherapy, while 70 patients in the control group were treated with radiotherapy alone. The radiation reactions during radiotherapy and the condition of late stage radiation injury radiotherapy in patients in the 2 groups were observed.
                The degree of oropharyngeal mucosa reaction, dryness in mouth and radiation dermatitis in cervical region in the observed group was milder than those in the control group, and the radiation injury induced late stage sequelae, such as the degree of mouth-opening was better and the cervical muscular sclerosis was better in the observed group than in the control group, showing significant difference (P < 0.01).
                SFR has definite effect in preventing and treating radiation reaction and late stage radiation injury in patients with head and neck tumor. Actinic keratoses (AK) are sun-induced epithelial skin lesions, which are at risk to progress to squamous cell carcinoma. One of the treatments of AK is photodynamic therapy (PDT), which often has to be repeated. Another treatment for these lesions is diclofenac 3% gel. Although both treatments have shown to be effective, they have never been studied together.
                To investigate whether a pre-treatment of AK on the dorsum of the hands with diclofenac 3% gel improves the efficacy of PDT.
                In this placebo-controlled, randomized, double-blind, pilot study with 10 patients, both hands were pre-treated--one with diclofenac gel and the other with placebo gel--and then the hands were treated with ALA-PDT. Total lesion number scores, total thickness scores and global improvement scores were used to assess efficacy. Pain scores were recorded during PDT.
                In both groups, the number of lesions significantly decreased. At 12 months' follow-up, significantly fewer AK were seen in the diclofenac group. Total lesion thickness scores decreased significantly in both groups. Pain during PDT was greater in the diclofenac group.
                Both treatments are effective in treating AK. A pre-treatment with diclofenac gel seems to result in fewer AK at 12 months' follow-up, compared to placebo. Side effects were worse when using the active drug. Photodynamic therapy (PDT) with methyl aminolaevulinate (MAL) is an effective treatment for multiple actinic keratoses (AKs). Pain, however, is a major side-effect.
                To compare pain intensity, efficacy, safety and cosmetic outcome of MAL PDT with two different light sources in an investigator-initiated, randomized, double-blind study.
                Eighty patients with multiple AKs grade I-II were assigned to two groups: group 1, MAL PDT with visible light and water-filtered infrared A (VIS+wIRA); group 2, MAL PDT with light from light-emitting diodes (LEDs), with a further division into two subgroups: A, no spray cooling; B, spray cooling on demand. MAL was applied 3 h before light treatment. Pain was assessed before, during and after PDT. Efficacy, side-effects, cosmetic outcome and patient satisfaction were documented after 2 weeks and 3, 6 and 12 months. Where necessary, treatment was repeated after 3 months.
                Seventy-six of the 80 patients receiving MAL PDT completed the study. Patient assessment showed high efficacy, very good cosmetic outcome and high patient satisfaction. The efficacy of treatment was better in the group of patients without spray cooling (P=0·00022 at 3 months, P=0·0068 at 6 months) and showed no significant differences between VIS+wIRA and LED. VIS+wIRA was significantly less painful than LED: the median of maximum pain was lower in the VIS+wIRA group than in the LED group for PDT without spray cooling. Pain duration and severity assessed retrospectively were less with VIS+wIRA than with LED, irrespective of cooling.
                All treatments showed high efficacy with good cosmetic outcome and high patient satisfaction. Efficacy of treatment was better without spray cooling. VIS+wIRA PDT was less painful than LED PDT for PDT without spray cooling.
                © 2010 The Authors. Journal Compilation © 2010 British Association of Dermatologists. Actinic keratoses (AK) frequently occur on sun-exposed skin and are considered as in situ squamous cell carcinoma. To date, no treatment algorithm exists for first or second line therapies due to the lack of comparative studies.
                This study compared the initial and 12-month clinical clearance, histological clearance, and cosmetic outcomes of topically applied 5% imiquimod (IMIQ) cream, 5% 5-fluorouracil (5-FU) ointment and cryosurgery for the treatment of AK.
                Patients were randomised to one of the following three treatment groups: one or two courses of cryosurgery (20-40 s per lesion), topical 5-FU (twice daily for 4 weeks), or one or two courses of topical imquimod (three times per week for 4 weeks each).
                Sixty-eight per cent (17/25) of patients treated with cryosurgery, 96% (23/24) of patients treated with 5-FU, and 85% (22/26) of patients treated with IMIQ achieved initial clinical clearance, p = 0.03. The histological clearance rate for cryosurgery was 32% (8/25), 67% (16/24) for 5-FU, and 73% (19/26) in the IMIQ group, p = 0.03. The 12-month follow-up showed a high rate of recurrent and new lesions in the 5-FU and cryosurgery arms. The sustained clearance rate of initially cleared individual lesions was 28% (7/25) for cryosurgery, 54% (13/24) for 5-FU and 73% (19/26) for IMIQ (p < 0.01). Sustained clearance of the total treatment field was 4% (1/25), 33% (8/24), and 73% (19/26) of patients after cryosurgery, 5-FU, and IMIQ, respectively (p < 0.01). The patients in the IMIQ group were judged to have the best cosmetic outcomes (p = 0.0001).
                Imiquimod treatment of AK resulted in superior sustained clearance and cosmetic outcomes compared with cryosurgery and 5-FU. It should be considered as a first line therapy for sustained treatment of AK. The clinical management of verrucae vulgaris is often challenging, and no ideal treatment currently exists. Early studies suggested that pulsed-dye laser (PDL) therapy might be highly effective in the treatment of verrucae, although more recent reports have been less optimistic. Previous studies have been retrospective or have consisted of a series of patients treated with PDL alone.
                Our objective was to prospectively evaluate the efficacy of PDL therapy versus conventional therapy with liquid nitrogen cryotherapy or cantharidin in the treatment of warts.
                Forty healthy adult patients with verrucae were randomized to receive either PDL (585 nm) therapy or conventional therapy. All enrollees also performed home therapy. Patients were eligible for up to 4 treatment sessions at 1-month intervals. Warts were individually counted and measured at the time of each treatment session. Complete response was defined as complete absence of verrucae with the presence of dermatoglyphics, and partial response was defined as a 50% or greater reduction in wart size.
                A total of 194 warts were evaluated by the conclusion of the study. Complete response was noted in an average of 70% of the warts treated with conventional therapy and in 66% of those in the PDL group; this was statistically insignificant. Partial response was observed in an average of 82% of the warts in patients treated with conventional therapy and 87% in the PDL group. Verruca vulgaris responded more readily than verruca plantaris in both treatment groups. The mean number of treatments to achieve success was similar in both groups.
                The PDL is an efficacious form of therapy for verrucae, as is conventional therapy. PDL therapy should be considered among the better established approaches in the treatment of warts, although data from this trial suggest that this approach is probably not superior. In a single-institution, double-blind, prospective, randomized trial, we determined whether oral aloe vera gel can reduce radiation-induced mucositis in head-and-neck cancer patients.
                We randomized 58 head-and-neck cancer patients between oral aloe vera and placebo. To be included in this Phase II protocol, patients had to be treated with radiotherapy with curative intent at Stanford University between February 1999 and March 2002. We examined patients biweekly for mucositis at 15 head-and-neck subsites and administered quality-of-life questionnaires.
                Patients in the aloe and placebo groups were statistically identical in baseline characteristics. By the end of treatment, the two groups were also statistically identical in maximal grade of toxicity, duration of Grade 2 or worse mucositis, quality-of-life scores, percentage of weight loss, use of pain medications, hydration requirement, oral infections, and prolonged radiation breaks.
                In our randomized study, oral aloe vera was not a beneficial adjunct to head-and-neck radiotherapy. The mean quality-of-life scores were greater in the aloe vera group, but the differences were not statistically significant. Oral aloe vera did not improve tolerance to head-and-neck radiotherapy, decrease mucositis, reduce soreness, or otherwise improve patient well-being. Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed.
                To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side-effects.
                A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age.
                Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one-half and SCIT to one-third of placebo treatment. No statistical significant difference between the two groups was observed. Both for symptoms and medication scores actively treated patients showed statistically significant and clinical relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects.
                Based on the limited number of patients the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile SLIT may be favored. A large proportion of the practice of radiotherapy in the management of metastatic adenocarcinoma of the prostate is associated with palliation of pain from osseous metastases and improving quality of life. Radiation therapy is well known to be effective in treating painful sites and may also be effective in reducing the propensity for adjuvantly treated disease to become symptomatic. Strontium-89 is a systemic radionuclide that has clinical efficacy in the palliation of pain from bony metastases.
                The study was a Phase-III randomized placebo control trial performed in eight Canadian Cancer Centers to evaluate the effectiveness of strontium-89 as an adjunct to local field radiotherapy. Patients with endocrine refractory metastatic prostate cancer received local field radiotherapy and either strontium-89 as a single injection of 10.8 mCi or placebo.
                One hundred twenty-six patients were recruited. No significant differences in survival or in relief of pain at the index site where noted. Intake of analgesics over time demonstrated a significant reduction in the arm treated with strontium-89. Progression of pain as measured by sites of new pain or the requirement for radiotherapy showed statistically significant differences between the arms in favor of strontium-89. Tumor makers including prostate specific antigen, acid phosphatase, and alkaline phosphatase were also reduced in patients receiving strontium-89. A Quality-of-Life analysis was performed as a multivariate data set and demonstrated an overall superiority of strontium-89 with alleviation of pain and improvement in physical activity being statistically significant. Toxicity was evaluated and demonstrated increased hematological toxicity in the group receiving strontium-89.
                It is concluded that the addition of strontium-89 is an effective adjuvant therapy to local field radiotherapy reducing progression of disease as evidenced by new sites of pain and the requirement of further radiotherapy and improving quality-of-life and need for analgesic support in this group of patients. Topical fluorouracil is currently approved for the treatment of actinic keratosis (AK) and is often used prior to or following cryosurgery as interval therapy in patients with severe AK lesions. No randomized, controlled studies are available to confirm anecdotal evidence suggesting pretreatment with fluorouracil is beneficial. This prospective, randomized, double-blind, vehicle-controlled study evaluated the effect of pretreatment with 0.5% fluorouracil cream (FC; Carac) or a vehicle cream (VC) once daily for 7 days to the face plus scalp, ears, neck, and/or lips in patients with > or = 5 visible or palpable AKs on the face prior to cryosurgery. Efficacy was determined by evaluating AK reduction and clearance (complete lack of AK lesions in the treatment area) at 4 weeks follow-up. Statistically significant decreases from baseline number of AKs were observed on all treatment areas in both groups. However, the mean number of facial AKs was significantly lower in the FC group at each treatment cycle (p = .011). No serious adverse events were considered related to treatment. Continuous, hyperfractionated, accelerated radiotherapy (CHART) has shown promise of improved tumour control and reduced late morbidity in pilot studies and has now been tested in a multicentre randomised controlled clinical trial.
                Patients with squamous cell cancer in the main sites within the head and neck region with the general exception of early T1 N0 tumours were entered into the study by 11 centres. There was a 3:2 randomisation to either CHART, where a dose of 54 Gy was given in 36 fractions over 12 days, or to conventional therapy where 66 Gy was given in 33 fractions over 6.5 weeks. A total of 918 patients were included over a 5 year period from March 1990.
                ACUTE MORBIDITY: Acute radiation mucositis was more severe with CHART, occurred earlier but settled sooner and was in nearly all cases healed by 8 weeks in both arms. Skin reactions were less severe and settled more quickly in the CHART treated patients. TUMOUR CONTROL AND SURVIVAL: Life table analyses of loco-regional control, primary tumour control, nodal control, disease-free interval, freedom from metastasis and survival showed no evidence of differences between the two arms. In exploratory subgroup analyses there was evidence of a greater response to CHART in younger patients (P = 0.041) and poorly differentiated tumours appeared to fare better with conventional radiotherapy (P = 0.030). In the larynx there was evidence of a trend towards increasing benefit with more advanced T stage (P = 0.002). LATE TREATMENT RELATED MORBIDITY: Osteoradionecrosis occurred in 0.4% of patients after CHART and 1.4% of patients after conventional radiotherapy. The incidence of chondritis or cartilage necrosis was similar in both arms. Life table analysis showed evidence of reduced severity in a number of late morbidities in favour of CHART. These were most striking for skin telangiectasia, superficial and deep ulceration of the mucosa and laryngeal oedema.
                Similar local turnout control was achieved by CHART as compared with conventional radiotherapy despite the reduction in total dose from 66 to 54 Gy supporting the importance of repopulation as a cause of radiation failure. The effects seen in advanced laryngeal cancer and those related to histological differentiation need further study. Reduced late morbidity is a factor which together with patient preference should be considered in the decision as to the programme of radiotherapy to employ in the curative treatment of head and neck cancer. Radiation-induced mucositis is an acute reaction of the mucosa of patients undergoing head and neck radiotherapy. It can have debilitating and dose-limiting consequences. There is no consensus on an accepted intervention that significantly reduces its severity. Misoprostol is a synthetic prostaglandin E1 analogue, with properties of a mucosal cytoprotectant. We designed a randomized, double-blind, placebo-controlled trial of misoprostol in patients with head and neck cancer. The aim of this study was to determine if topical misoprostol was effective in reducing the severity of radiation-induced mucositis in patients receiving radical dose radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of Radiation Therapy Oncology Group grade 3 mucositis. Between 1999 and 2002, 83 patients were recruited into the study at Westmead and Nepean Hospitals, Sydney. Forty-two patients were randomized to receive misoprostol and 41 to receive a placebo. Most patients received radiotherapy in the adjuvant setting (52 of the 83) and had either an oral cavity (42 of the 83) or an oropharyngeal (16 of the 83) cancer. We could not identify any significant difference in the incidence of severe mucositis based on whether patients were allocated to receive misoprostol or placebo. There was no significant difference in the mean area under the mucositis curve (13.2 vs 16.6; P = 0.1). Patients allocated to misoprostol did report slightly increased soreness (7.6 vs 6.9; P = 0.04) and a greater use of analgesics. However, this difference did not translate into a worse feeling of general well-being as measured by a simple visual analogue scale (5.8 vs 5.2; P = 0.3). In conclusion, we were unable to identify a reduction in radiation-induced mucositis in patients receiving misoprostol. There is a paucity of high-level evidence on potentially useful interventions and a continued need for new and innovative research, incorporating quality-of-life measurements, in patients experiencing radiation-induced mucositis. Stomatitis is a major dose-limiting toxicity of bolus fluorouracil (5FU)-based chemotherapy regimens, despite the use of oral cryotherapy. Pursuant to preliminary data that suggested a sucralfate oral solution could alleviate chemotherapy-induced oral mucositis, we developed a prospective trial to test this contention.
                A phase III, double-blind, placebo-controlled clinical trial was designed. Patients were entered onto the study at the time of the first cycle of 5FU-based chemotherapy. All patients received oral cryotherapy for 30 minutes with each dose of 5FU. In addition, each patient was randomized to receive either a sucralfate solution or a placebo solution to be used if they developed mouth tenderness or mouth sores. The study solution was to be used four times daily for 7 days starting on the first day of mouth tenderness or mouth sores. Stomatitis scores were determined by health care providers and by patients themselves.
                There was a total of 131 assessable patients entered onto this trial, 50 of whom developed mucositis and used the study medication (27 sucralfate and 23 placebo). There was no suggestion of any difference in stomatitis severity or duration on either protocol arm.
                The resultant data from this clinical trial did not support the prestudy hypothesis that sucralfate would be beneficial for the treatment of 5FU-induced stomatitis. The purpose of this placebo-controlled, double-blind study was to determine the safety, tolerability and clinical efficacy of 5-fluorouracil (1%) in a vaginal hydrophilic gel (hydroxyethylcellulose, 1%) to cure intravaginal papillomas in women. Pre-selected, 60 women ranging between 18 and 50 years of age (mean 24.6), having 312 vaginal condylomas (mean 5.2) joined the study. The diagnosis of human papillomavirus (HPV) was established with clinical, histopathological and polymerase chain reaction (PCR) techniques. Subjects were randomized into 2 parallel groups. Each patient was allocated a pre-coded tube 15 g (active or placebo) with graduated vaginal applicators (disposable), and instructions how to insert 4 g of the trial medication deep into the vagina once at bedtime on every other day (1, 3 and 5) per week, to visit the clinic on day 7 for clinical evaluations and to receive the same pre-coded replacement to continue the regimen for another week. A maximum 12 applications were to be used in 4 weeks. Cure was defined as absence of clinical signs of infection, re-confirmed by PCR and Southern blot hybridization negative HPV DNA. By the end of the treatment 48.4% patients and 51.9% lesions were cured. Breaking the code revealed that 5-fluorouracil (1%) gel had cured 83.3% patients and 87% intravaginal warts. Placebo resolved 13.3% patients and 14% condylomas; (active gel versus placebo; P < 0.001). Twelve patients (20%) mostly in the active gel experienced mild erythema, erosion and oedema, with no drop-outs. Among cured patients 3 had a relapse after 16 months. In conclusion, the clinical results of the study demonstrate that 5-fluorouracil (1%) in a vaginal hydrophilic gel is safe, tolerable and significantly more effective than placebo to cure intravaginal warts in women. The study compared, by a prospective, randomized method, 6 treatment options: A: Sclerotherapy; B: High-dose sclerotherapy; C: Multiple ligations; D: Stab avulsion; E: Foam-sclerotherapy; F: Surgery (ligation) followed by sclerotherapy. Results were analyzed 10 years after inclusion and initial treatment. Endpoints of the study were variations in ambulatory venous pressure (AVP), refilling time (RT), presence of duplex-reflux, and number of recurrent or new incompetent venous sites. The number of patients, limbs, and treated venous segments were comparable in the 6 treatment groups, also comparable for age and sex distribution. The occurrence of new varicose veins at 5 years varied from 34% for group F (surgery + sclero) and ligation (C) to 44% for the foam + sclero group (E) and 48% for group A (dose 1 sclero). At 10 years the occurrence of new veins varied from 37% in F to 56% in A. At inclusion AVP was comparable in the different groups. At 10 years the decrease in AVP and the increase in RT (indicating decrease in reflux), was generally comparable in the different groups. Also at 10 years the number of new points of major incompetence was comparable in all treatment groups. These results indicate that, when correctly performed, all treatments may be similarly effective. "Standard," low-dose sclerotherapy appears to be less effective than high-dose sclero and foam-sclerotherapy which may obtain, in selected subjects, results comparable to surgery. A new topical formulation of betamethasone valerate (BMV) with enhanced dermal penetration has been developed.
                These studies were designed to evaluate: (1) the relative bioavailability of BMV foam, and (2) the safety and efficacy of BMV foam in the treatment of scalp psoriasis as compared to a lotion formulation of BMV and placebo.
                Safety and efficacy were evaluated in a randomized, multicenter, double-blind, active-and placebo-controlled trial in adult patients with moderate to severe scalp psoriasis. A separate study in 18 patients was conducted to evaluate the potential for suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Relative bioavailability was measured using the human cadaver skin model.
                72% of patients using BMV foam were clear or almost clear of disease at the end of 28-days of treatment as judged by the investigator's global assessment of response. Only 47% of BMV lotion patients and 21% of placebo showed a similar level of response. There was no evidence of increased toxicity or HPA-axis suppression for BMV foam, but assessment of relative bioavailability showed BMV penetration into the skin to be more than two-fold greater than from BMV lotion.
                A novel foam formulation with enhanced BMV bioavailability has been shown to be of increased efficacy in the treatment of scalp psoriasis without an associated increase in toxicity. To investigate the efficacy of topical cyclosporine A 0.05% (tCsA) (Restasis, Allergan Pharmaceuticals) in the treatment of meibomian gland dysfunction (posterior blepharitis).
                Thirty-three patients with symptomatic meibomian gland dysfunction were randomized in a prospective study to either tCsA or placebo (Refresh Plus preservative-free artificial tears), 2 times daily for 3 months. They were evaluated at baseline and at 1, 2, and 3 months for subjective symptoms and objective signs including meibomian gland inclusions, lid margin vascular injection, tarsal telangiectasis, fluorescein staining, tear breakup time, and Schirmer scores.
                Twenty-six patients completed the study. All patients were tested for ocular symptoms, lid margin vascularity, tarsal telangiectasis, meibomian gland inclusions, tear breakup time, and fluorescein staining. At the 3-month visit, the tCsA group showed a greater improvement in ocular symptoms than the placebo group, but this difference was not statistically significant. At the 3-month visit, several objective examination findings were statistically significantly (P < 0.05) improved in the tCsA group compared with the placebo group. These differences included lid margin vascular injection, tarsal telangiectasis, and fluorescein staining. The most significant finding (P = 0.001) was the greater decrease in the number of meibomian gland inclusions in the tCsA group compared with the placebo group.
                Topical CsA may be helpful in the treatment of meibomian gland dysfunction (posterior blepharitis). Topical CsA did not induce an improvement in the symptoms, but it did decrease the number of meibomian gland inclusions in patients with meibomian gland dysfunction. The application of crushed ice or hydrogenated silicate, a micro-crystalline substitute has been used as a method to treat posttraumatic and postoperative irritations of the locomotor system for a long time. Closed systems using pumps can be viewed as further development as they enable continuous, water-free cooling of operating areas. The analgetic effect of postoperative cold therapy was evaluated in a prospective clinical trial, including 312 patients after total knee or hip arthroplasty. Conventional cold packs, consisting of microcrystalline silicate were compared to a continuous applicable closed system. Continuous cryotherapy resulted in a depression of skin temperature to 12 degrees C, whereas intermittent cooling only caused a mean temperature decrease of 1 degree C. Clinically continuous cold application leads to a more than 50% decrease of analgetic demands in both, systemic and regional application (p < 0.001). This observation was found in a significant correlation with patient's pain sensation as well as primary range of motion. Intermittent cryotherapy was found to be ineffective in postoperative pain relieve in hip- and adequate in knee arthroplasty patients. We could not report an influence on postoperative blood loss, as discussed in previous reports. The aim of this study was to compare the efficacy of ultrasound (US) and ketoprofen phonophoresis (PH) in the treatment of carpal tunnel syndrome (CTS).
                This study was a prospective, randomised, controlled, double-blinded clinical trial with follow-up at 8 weeks. Fiftyone patients (76 median nerves) with clinical and electrophysiologic evidence of mild or moderate CTS were included in the study. They were randomly assigned to one of three groups; group 1 received sham US and splinting, group 2 received US and splinting, and group 3 received ketoprofen phonophoresis and splinting. Patients were evaluated by use of electrophysiological variables such as median motor distal latency (mMDL), median sensory distal latency (mSDL), functional status scale (FSS), symptom severity scale (SSS) and visual analog scale (VAS). Electrophysiological variables and scales were evaluated at the beginning, end of therapy (2nd week) and 8th week.
                All the randomised patients were included in the intention-to-treat (ITT) analysis. The per protocol (PP) analysis included only those patients who complied with the study protocol. After completing 2 weeks of treatment, seven out of 51 randomized patients did not finish the study protocol due to non-compliance to splinting, illness and lost to follow-up. Those patients were excluded from PP analysis. Participants were similar in all clinical, electrophysiological and demographic respects (p>0.05). An improvement was found in all parameters (VAS, FSS, SSS, mMDL and mSDL) for all groups at the end of the treatment and 8th week. It was found that pain score was significantly lower in group 3 compared to other treatment groups at 8th week according to ITT and PP analysis (p= 0.002, p=0.004 and p=0.001, p=0.001).
                Ketoprofen PH as adjuvant therapy on splinting is effective with respect to reduction of pain. Adding US therapy to the splinting is not superior to the splinting alone in patients with CTS.
Data from two new trials comparing SA and cryotherapy have allowed a better appraisal of their effectiveness. The evidence remains more consistent for SA, but only shows a modest therapeutic effect. Overall, trials comparing cryotherapy with placebo showed no significant difference in effectiveness, but the same was also true for trials comparing cryotherapy with SA. Only one trial showed cryotherapy to be better than both SA and placebo, and this was only for hand warts. Adverse effects, such as pain, blistering, and scarring, were not consistently reported but are probably more common with cryotherapy.
None of the other reviewed treatments appeared safer or more effective than SA and cryotherapy. Two trials of clear duct tape demonstrated no advantage over placebo. Dinitrochlorobenzene (and possibly other similar contact sensitisers) may be useful for the treatment of refractory warts.