K Peris1, E Stockfleth2, G Gupta3, S Aractingi4,5, R Dakovic6, T Dirschka7,8, A Alomar9. 1. Department of Dermatology, Catholic University of Rome, Rome, Italy. 2. Department of Dermatology, Charité - University Medical Centre Berlin, Berlin, Germany. 3. Department of Dermatology, Monklands Hospital, Airdrie, Lanarkshire, UK. 4. Service de Dermatologie Allergologie, Hôpital Cochin, Paris, France. 5. Université Paris 5 Descartes, Paris, France. 6. Meda Pharma GmbH & Co. KG, Bad Homburg, Germany. 7. Dermatological Practice Centre, Wuppertal, Germany. 8. Faculty of Health, University Witten-Herdecke, Witten, Germany. 9. Department of Dermatology, Institut Universitari Quiron Dexeus, Barcelona, Spain.
Abstract
BACKGROUND:Imiquimod 3.75% reduces 92.2% of all actinic keratosis (AK) lesions, assumed to include both subclinical and clinical lesions, across a large sun-exposed field such as the full face or balding scalp. OBJECTIVE: To evaluate the efficacy of imiquimod 3.75% using the reduction in lesions from Lmax (the maximum lesion count during treatment) in subgroups of patients with low and high AK lesion counts. METHODS: Patients from two 14-week, placebo-controlled, double-blind studies were subgrouped according to whether they had ≤ 10 or >10 AK lesions at baseline. Treatment was applied to the full face or balding scalp during two 2-week treatment cycles separated by a 2-week treatment-free interval. RESULTS: Overall, 167 patients had ≤ 10 lesions and 152 patients had >10 AK lesions at baseline. With imiquimod 3.75%, the median percentage reduction in AK lesions from Lmax to end of study was similar in patients with ≤ 10 and >10 baseline lesions (91.5% and 93.0% respectively). The median absolute reduction in AK lesions from Lmax to end of study was 24.0 for patients with >10 baseline lesions and 10.0 for those with ≤ 10 baseline lesions. The median percentage and absolute reductions in lesions from Lmax were significantly greater with imiquimod 3.75% vs. placebo (P < 0.0001). CONCLUSIONS:Imiquimod 3.75% is effective regardless of disease severity as shown in this study by the reduction of over 90% of lesions from Lmax in patients with low or high AK lesion counts.
RCT Entities:
BACKGROUND: Imiquimod 3.75% reduces 92.2% of all actinic keratosis (AK) lesions, assumed to include both subclinical and clinical lesions, across a large sun-exposed field such as the full face or balding scalp. OBJECTIVE: To evaluate the efficacy of imiquimod 3.75% using the reduction in lesions from Lmax (the maximum lesion count during treatment) in subgroups of patients with low and high AK lesion counts. METHODS:Patients from two 14-week, placebo-controlled, double-blind studies were subgrouped according to whether they had ≤ 10 or >10 AK lesions at baseline. Treatment was applied to the full face or balding scalp during two 2-week treatment cycles separated by a 2-week treatment-free interval. RESULTS: Overall, 167 patients had ≤ 10 lesions and 152 patients had >10 AK lesions at baseline. With imiquimod 3.75%, the median percentage reduction in AK lesions from Lmax to end of study was similar in patients with ≤ 10 and >10 baseline lesions (91.5% and 93.0% respectively). The median absolute reduction in AK lesions from Lmax to end of study was 24.0 for patients with >10 baseline lesions and 10.0 for those with ≤ 10 baseline lesions. The median percentage and absolute reductions in lesions from Lmax were significantly greater with imiquimod 3.75% vs. placebo (P < 0.0001). CONCLUSIONS: Imiquimod 3.75% is effective regardless of disease severity as shown in this study by the reduction of over 90% of lesions from Lmax in patients with low or high AK lesion counts.