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Two‐year interim results from a 5‐year study evaluating clinical recurrence of superficial basal cell carcinoma after treatment with imiquimod 5% cream daily for 6 weeks
Author(s) -
Quirk Chris,
Gebauer Kurt,
Owens Mary,
Stampone Patti
Publication year - 2006
Publication title -
australasian journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.67
H-Index - 53
eISSN - 1440-0960
pISSN - 0004-8380
DOI - 10.1111/j.1440-0960.2006.00313.x
Subject(s) - medicine , imiquimod , dosing , erythema , basal cell carcinoma , interim analysis , clinical trial , regimen , surgery , dermatology , basal cell
SUMMARY Imiquimod 5% cream is approved in the USA, Europe and Australia to treat superficial basal cell carcinoma, using a regimen of once daily, 5 times per week for 6 weeks. Vehicle‐controlled, phase III clinical trials show that imiquimod is safe and effective for treating superficial basal cell carcinoma with dosing 5 or 7 times per week for 6 weeks. This phase III, open‐label study evaluates the long‐term (5 years) clinical efficacy and safety of dosing once daily, for which this manuscript reports the 2‐year time point in the follow‐up period. For the 169 enrolled subjects, the tumour selected for treatment was assessed clinically to determine initial clearance at the 12‐week post‐treatment visit. If clinically clear of superficial basal cell carcinoma, subjects entered a 5‐year, long‐term follow‐up period. Subjects were evaluated for recurrence at the 3‐, 6‐, 12‐ and 24‐month follow‐up visits. The initial clearance rate at 12 weeks post treatment was 94.1%. The proportion of subjects who were clinically clear at the 2‐year follow‐up visit was estimated to be 82.0%. Imiquimod was tolerated when applied daily, with erythema reported for all subjects participating in the study. The recurrence rate observed suggests that once daily dosing and 5×/week dosing yield similar clearance rates, but daily dosing increases local skin reactions.