James Del Rosso1,2,3,4,5,6, Neil Swanson1,2,3,4,5,6, Brian Berman1,2,3,4,5,6, George M Martin1,2,3,4,5,6, Tina Lin1,2,3,4,5,6, Ted Rosen1,2,3,4,5,6. 1. Dr. Del Rosso is with JDR Dermatology Research/Thomas Dermatology in Las Vegas, Nevada. 2. Dr. Swanson is with the Department of Dermatology at Oregon Health and Science University in Portland, Oregon. 3. Dr. Berman is with the Department of Dermatology and Cutaneous Surgery at the Miller School of Medicine, University of Miami in Miami, Florida and the Center for Clinical and Cosmetic Research in Aventura, Florida. 4. Dr. Martin is with the Dermatology and Laser Center of Maui in Maoi, Hawaii. 5. Dr. Lin is with Valeant Pharmaceuticals in Bridgewater, New Jersey. 6. Dr. Rosen is with the Department of Dermatology at Baylor College of Medicine in Houston, Texas.
Abstract
Background: Ad-hoc reports within clinical studies of imiquimod for the treatment of actinic keratosis (AK) have suggested the drug can improve both skin texture and overall signs of photodamage. Objective: We sought to assess the efficacy and tolerability of imiquimod 3.75% and 2.5% cream for the treatment of photodamage in patients with AK of the full face or balding scalp. Methods: A meta-analysis of four identical multicenter, randomized, double-blind, vehicle-controlled studies was conducted. The studies included a total of 969 adult subjects (aged 33-91 years) with 5 to 20 visible lesions or palpable AKs in an area exceeding 25cm2 on either the face or balding scalp. Patients were randomized to imiquimod 3.75%, imiquimod 2.5%, or vehicle cream (1:1:1). Up to two packets (250mg each) were applied per dose once daily for two two-week treatment cycles, separated by a two-week no-treatment interval. Photodamage improvement was assessed at study end based on subjects' baseline assessments using a seven-point scale. Local skin reactions were recorded throughout the study. Results: Combined Investigator's Global Integrated Photodamage (IGIP) score was "significantly" or "much" improved in 57.6 percent (n=175) of patients treated with imiquimod 2.5% cream and in 69.6 percent (n=208) of patients treated with imiquimod 3.75% cream versus in 25.7 percent (n=76) of patients treated with the vehicle. Mean IGIP scores at end of study were 1.67, 1.98, and 0.73, respectively (both actives P<0.0001 versus vehicle). Conclusion: Both imiquimod 2.5% and 3.75% creams showed a positive effect on photodamage when compared with the vehicle cream.
RCT Entities:
Background: Ad-hoc reports within clinical studies of imiquimod for the treatment of actinic keratosis (AK) have suggested the drug can improve both skin texture and overall signs of photodamage. Objective: We sought to assess the efficacy and tolerability of imiquimod 3.75% and 2.5% cream for the treatment of photodamage in patients with AK of the full face or balding scalp. Methods: A meta-analysis of four identical multicenter, randomized, double-blind, vehicle-controlled studies was conducted. The studies included a total of 969 adult subjects (aged 33-91 years) with 5 to 20 visible lesions or palpable AKs in an area exceeding 25cm2 on either the face or balding scalp. Patients were randomized to imiquimod 3.75%, imiquimod 2.5%, or vehicle cream (1:1:1). Up to two packets (250mg each) were applied per dose once daily for two two-week treatment cycles, separated by a two-week no-treatment interval. Photodamage improvement was assessed at study end based on subjects' baseline assessments using a seven-point scale. Local skin reactions were recorded throughout the study. Results: Combined Investigator's Global Integrated Photodamage (IGIP) score was "significantly" or "much" improved in 57.6 percent (n=175) of patients treated with imiquimod 2.5% cream and in 69.6 percent (n=208) of patients treated with imiquimod 3.75% cream versus in 25.7 percent (n=76) of patients treated with the vehicle. Mean IGIP scores at end of study were 1.67, 1.98, and 0.73, respectively (both actives P<0.0001 versus vehicle). Conclusion: Both imiquimod 2.5% and 3.75% creams showed a positive effect on photodamage when compared with the vehicle cream.
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