Phase III vehicle-controlled, multi-centered study of topical alitretinoin gel 0.1% in cutaneous AIDS-related Kaposi's sarcoma. Topical chemotherapy of actinic keratoses of the upper extremity with tretinoin and 5-fluorouracil: a double-blind controlled study. The safety and efficacy of tazarotene gel, a topical acetylenic retinoid, in the treatment of psoriasis.
This randomized, double-blind and vehicle-controlled phase III study was conducted to evaluate the efficacy and safety of alitretinoin gel 0.1% for the topical treatment of the cutaneous lesions of AIDS-related Kaposi's sarcoma (KS).
                Patients received treatment with alitretinoin gel (n = 62) or vehicle gel (n = 72) twice daily for 12 weeks. The primary efficacy endpoint was the cutaneous KS tumor response rate according to AIDS Clinical Trials Group (ACTG) objective criteria applied to topical therapy, with the patient as the unit of analysis.
                Treatment of patients with alitretinoin gel resulted in a significant antitumor effect. The overall patient response rate (complete plus partial response) was 37% (23 of 62) for the alitretinoin-treated patients and 7% (5 of 72) for the vehicle-treated patients (p = 0.00003). The difference in response rates for the 2 treatment groups remained significant even after taking into consideration numerous variables, including age (p = 0.00001), Eastern Cooperative Oncology Group (ECOG) status (p = 0.00002), CD4+ cell count (p = 0.00002), history of opportunistic infection (p = 0.00002), aggregate area of indicator lesions (p = 0.00005), number of raised indicator lesions (p = 0.00002), prior therapy for KS (p = 0.00003), and number of drugs (p = 0.00002) used in concomitant antiretroviral therapy. Generally, treatment with alitretinoin gel was well tolerated. The overall incidence of adverse events was similar for the 2 treatment groups. Adverse events related to treatment with alitretinoin gel tended to be mild to moderate in severity and limited to the site of application. The most frequent adverse event occurring at the application site following alitretinoin gel treatment was irritation coded as rash (32%).
                The results of this study provide convincing evidence of the superiority of alitretinoin gel over vehicle gel for the treatment of the cutaneous lesions of AIDS-related KS. In a randomized double-blind controlled study, 19 patients applied 5% 5-fluorouracil (5-FU) cream to actinic keratoses (AK) on each arm twice daily, followed by nightly application of 0.05% tretinoin cream to one arm, and a control cream to the other arm until discomfort precluded further applications. After 3 months, the number of residual AK was compared to pre-treatment values. The tretinoin-treated arms had 15.7 +/- 6.1 AK before treatment and 3.4 +/- 2.6 AK following therapy. The control arms had 15.3 +/- 6.9 AK before therapy and 4.2 +/- 2.5 lesions afterwards. Using a one-tailed paired t-test, the difference in response was statistically significant (0.03 less than P less than 0.04). It was concluded that daily application of 0.05% tretinoin cream appeared to enhance the efficacy of topical 5-FU in destruction of AK of the arms and may represent a useful treatment modality. To determine the safety and efficacy of topically applied tazarotene gel in the treatment of mild to moderate psoriatic plaques.
                Two multicenter, double-blind, randomized studies of 6- and 8-week duration, with an 8-week follow-up in the second study.
                Medical center outpatient dermatology services.
                One hundred fifty-three adults with 2 bilateral target plaques on the trunk, legs, or arms.
                Vehicle gel or 0.01% and 0.05% tazarotene gel administered twice daily to 45 patients (study A), or 0.05% and 0.1% tazarotene gel administered either once or twice daily to 108 patients (study B).
                Treatment success and plaque elevation, scaling, and erythema vs time.
                The 0.01% tazarotene gel showed minimal efficacy. Applications of 0.05% and 0.1% tazarotene gels administered once or twice daily, resulted in significant improvements in plaque elevation, scaling, erythema, and overall clinical severity as early as 1 week. Treatment success rates (defined as > 75% improvement from baseline) were 45% with 0.05% tazarotene gel vs 13% with vehicle gel after 6 weeks of treatment (P < .05; study A) and ranged from 48% to 63% with the various tazarotene treatment regimens after 8 weeks of treatment (study B). These improvements were evident at the 8-week follow-up. Treatment-related adverse effects were generally limited to mild or moderate local irritation and were less frequent with the treatment regimen administered once daily.
                The 0.05% and 0.1% tazarotene gels demonstrated significant efficacy in the treatment of mild to moderate psoriatic plaques that persisted after cessation of treatment.
Alitretinoin gel is effective in treating cutaneous KS, PLD is effective treatment for advanced KS and radiotherapy appears effective in treating cutaneous lesions. Apart from the trial of radiotherapy no trials applicable to developing settings were identified.