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document
A randomized , double-blind , vehicle-controlled study to assess 5 % imiquimod cream for the treatment of multiple actinic keratoses . BACKGROUND Actinic keratoses ( AKs ) are precancerous epidermal lesions found most frequently on areas of the skin exposed to the sun . Several case studies published recently have indicated that 5 % imiquimod cream , currently licensed for the treatment of genital warts , may be an effective treatment for AK . OBJECTIVE To assess the efficacy and safety of imiquimod for the treatment of AK . DESIGN Patients in this randomized , double-blind , vehicle-controlled study applied 5 % imiquimod cream or vehicle to AK lesions 3 times per week for a maximum of 12 weeks or until lesions had resolved . In the event of an adverse reaction , application of imiquimod was reduced to 1 or 2 times per week . Rest periods were also allowed if necessary . SETTING A specialized outpatient dermatology clinic within a state-funded hospital in Germany . PATIENTS The study population was aged 45 to 85 years . Of 52 patients screened , 36 men and women with AK confirmed by histological diagnosis were enrolled . Patients were excluded from the study if they did not have a histological diagnosis for AK , if they were older than 85 years , or if they did not comply with the protocol . All patients had responded to a notice asking for volunteers . MAIN OUTCOME MEASURES The number and appearance of lesions were evaluated before , during , and after treatment . All adverse effects were recorded . RESULTS Lesions treated with 5 % imiquimod cream were clinically cleared in 21 ( 84 % ) of 25 patients and partially cleared in 2 ( 8 % ) . Clearance was histologically confirmed 2 weeks after the last application of imiquimod in all patients clinically diagnosed as lesion free . Only 10 % of patients treated with imiquimod were clinically diagnosed with recurrence 1 year after treatment . No reduction in the size or number of AK lesions was observed in vehicle-treated patients . Adverse effects reported by patients treated with imiquimod included erythema , edema , induration , vesicles , erosion , ulceration , excoriation , and scabbing . However , imiquimod was well tolerated since all patients completed the 12-week treatment . Only a few , mild adverse reactions to the vehicle cream were reported . CONCLUSION Application of 5 % imiquimod cream for 12 weeks is an effective and well-tolerated treatment for AK .
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Intervention_Pharmacological
imiquimod cream
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Intervention_Pharmacological
imiquimod cream
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Intervention_Pharmacological
imiquimod
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Intervention_Pharmacological
imiquimod cream
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Intervention_Pharmacological
imiquimod
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Intervention_Pharmacological
imiquimod
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Intervention_Pharmacological
imiquimod
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Intervention_Pharmacological
imiquimod cream
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Outcome_Physical
multiple actinic keratoses
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Outcome_Physical
Actinic keratoses ( AKs )
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Outcome_Physical
AK
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Outcome_Physical
AK lesions
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Outcome_Physical
number and appearance of lesions
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Outcome_Adverse-effects
adverse effects
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Outcome_Physical
clinically cleared
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Outcome_Physical
partially cleared
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Outcome_Physical
Clearance
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Outcome_Physical
reduction in the size or number of AK lesions
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Outcome_Adverse-effects
erythema , edema , induration , vesicles , erosion , ulceration , excoriation , and scabbing
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Outcome_Other
tolerated
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Outcome_Physical
AK
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Participant_Condition
multiple actinic keratoses
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Participant_Age
45 to 85
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Participant_Sample-size
52
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Participant_Sex
men and women