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 2-week cycles
Section snippets
Study population
Adults in general good health with 5 to 20 visible or palpable AKs, as determined by clinical assessment by the investigator, in an area greater than 25 cm2 on either the face or the balding scalp, but not both, were eligible for participation in the studies. A study patient could not have any significant condition in the treatment area that might impair evaluation, have atypical AKs (eg, AK > 1 cm2), be pregnant or lactating, have a chemical or alcohol dependency, or have an allergy to
Patient population
In the combined studies, 479 male and female patients (Fig 2) were enrolled and 453 completed the studies. The most frequent cause of discontinuation was personal reasons (10 patients), followed by AEs (6 patients). Overall, patients were predominantly male (>80%) and white (>99%), had a mean age of 64 years, and were predominantly treated on the face (>74%). The treatment groups were considered comparable with respect to demographic characteristics within and across the two studies (Table I).
Discussion
The results of these two studies indicate that imiquimod 2.5% and 3.7% creams are effective in treating AKs on the full face or scalp in a short cyclical treatment regimen. For all efficacy outcomes, both imiquimod 2.5% and 3.75% were superior to placebo. In addition, imiquimod 3.75% was superior to 2.5% with respect to partial clearance rates and percent reductions in AKs lesions. Both imiquimod creams were well tolerated, with very few patients discontinuing from the study and more than 90%
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2021, Journal of the American Academy of DermatologyCitation Excerpt :A subset of the studies on 12 to 56 doses of 5% imiquimod report participant rates of discontinuation of treatment due to adverse events ranging from 1.6% to 33.3% (average 12.6%; Supplemental e-Table 2d). Four placebo-controlled studies provided data on the efficacy of 3.75% imiquimod cream for the treatment of AKs on the face and scalp (Supplemental e-Table 2e).61,62,64,68 A study of 3.75% imiquimod applied daily for two 3-week periods separated by 3 weeks off treatment reports that at 17 weeks the post treatment rates of complete clearance were 34% and 5.5% for imiquimod and placebo-treated patients, respectively (risk ratio [RR] 6.19; 95%CI, 3.16-12.10; P < .0001).61
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Funding sources: Graceway Pharmaceuticals LLC.
Disclosure: Dr Swanson was an investigator and consultant for Graceway, and has received compensation for services. Dr Abramovits was an investigator and speaker for Graceway and has received compensation for services. Dr Berman was an advisory board member and speaker for Graceway and has received compensation for services. Mr Kulp and Dr Levy are employees of Graceway. Dr Rigel was a consultant, advisory board member, and investigator for Graceway and has received compensation for services.