Original articleImiquimod 2.5% and 3.75% for the treatment of actinic keratoses: Results of two placebo-controlled studies of daily application to the face and balding scalp for two 3-week cycles
Section snippets
Study population
Adults in general good health with 5 to 20 visible or palpable AKs in an area greater than 25 cm2 in size on either the face or the balding scalp, but not both, were eligible for participation in the studies. A study subject could not have any significant condition in the treatment area that might impair evaluation, have atypical AKs (eg, AK >1 cm2 in size), be pregnant or lactating, have a chemical or alcohol dependency, or have a known allergy to imiquimod or study cream excipients. Prior
Subject population
In the combined studies, 490 male and female patients (Fig 2) were enrolled and 463 completed the studies. The most frequent reason for discontinuation was for personal reasons (11 subjects), followed by AEs (7 subjects). The majority of subjects were male (79%), white (99%), and treated the face (72%); their mean age was 65 years (Table I). The treatment groups were considered comparable with respect to demographic characteristics within and across the two studies. Overall, 96% of subjects
Discussion
In two multicenter studies conducted in parallel, both imiquimod 2.5% cream and imiquimod 3.75% cream were safe and effective in treating AKs on the full face or balding scalp when applied as a 3-week on/off/on treatment regimen. Each of the imiquimod creams was superior to placebo cream with respect to complete clearance rates, partial clearance rates, and median percent lesion reductions. These efficacy outcomes were greater in the imiquimod 3.75% group compared with the 2.5% group, although
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Supported by Graceway Pharmaceuticals LLC.
Disclosure: Drs Hanke and Beer were investigators and consultants for Graceway and received compensation for services. Drs Stockfleth and Rosen were consultants for Graceway and received compensation for services. Drs Wu and Levy are employees of Graceway.