Eggert Stockfleth1, Girish Gupta2, Ketty Peris3, Selim Aractingi4, Rada Dakovic5, Agustin Alomar6. 1. Department of Dermatology, Charité - University Medical Centre Berlin, Charité Platz 1, Berlin, D-10117, Germany. 2. Department of Dermatology, Monklands Hospital, Airdrie, Lanarkshire, ML6 0JS, UK. 3. Department of Dermatology, University of L'Aquila, Via Vetoio - Coppito 2, 67100 L'Aquila, Italy. 4. Service de Dermatologie Allergologie, Hôpital Cochin, 89 rue d'Assas, 75006 Paris, France and Université Paris 5 Descartes, Paris, France. 5. Meda Pharma GmbH & Co. KG, Benzstrasse 1, 61353 Bad Homburg, Germany. 6. Department of Dermatology, Institut Universitari Dexeus, Av. Carles III 71-75, 8028 Barcelona, Spain.
Abstract
BACKGROUND: Current parameters for assessing the efficacy of actinic keratosis (AK) treatments compare clinical lesions at the start and end of a study. However, the sun-exposed field also contains subclinical lesions which may become detectable during treatment. Lmax, the maximum lesion count during treatment, is a new concept to better assess the efficacy of field-directed AK therapies. Measuring efficacy using the reduction in lesions from Lmax includes for the first time the clearance of both subclinical and clinical lesions. OBJECTIVES: To evaluate the reduction of lesions from Lmax to study end and compare the results with traditional efficacy endpoints using imiquimod 3.75% (IQ3.75%) as an example of field-directed AK therapy. MATERIALS & METHODS: Pooled analysis of data from two 14-week, vehicle-controlled, double-blind studies of IQ3.75%. RESULTS: With IQ3.75%, the median number of lesions increased from 10 at baseline to an Lmax of 22. The median absolute reduction in lesions to study end was 18 from Lmax versus 7 from baseline. The median percentage reduction in AK lesions to study end was 92.2% from Lmax compared with 81.8% from baseline. CONCLUSIONS: The reduction in lesion count from Lmax is a novel efficacy parameter that should become the new way of evaluating field-directed AK therapies since it enables their efficacy against both clinical and subclinical lesions to be accurately determined. Together, the Lmax concept and IQ3.75% represent a new approach for the management of AK across a large sun-exposed field.
RCT Entities:
BACKGROUND: Current parameters for assessing the efficacy of actinic keratosis (AK) treatments compare clinical lesions at the start and end of a study. However, the sun-exposed field also contains subclinical lesions which may become detectable during treatment. Lmax, the maximum lesion count during treatment, is a new concept to better assess the efficacy of field-directed AK therapies. Measuring efficacy using the reduction in lesions from Lmax includes for the first time the clearance of both subclinical and clinical lesions. OBJECTIVES: To evaluate the reduction of lesions from Lmax to study end and compare the results with traditional efficacy endpoints using imiquimod 3.75% (IQ3.75%) as an example of field-directed AK therapy. MATERIALS & METHODS: Pooled analysis of data from two 14-week, vehicle-controlled, double-blind studies of IQ3.75%. RESULTS: With IQ3.75%, the median number of lesions increased from 10 at baseline to an Lmax of 22. The median absolute reduction in lesions to study end was 18 from Lmax versus 7 from baseline. The median percentage reduction in AK lesions to study end was 92.2% from Lmax compared with 81.8% from baseline. CONCLUSIONS: The reduction in lesion count from Lmax is a novel efficacy parameter that should become the new way of evaluating field-directed AK therapies since it enables their efficacy against both clinical and subclinical lesions to be accurately determined. Together, the Lmax concept and IQ3.75% represent a new approach for the management of AK across a large sun-exposed field.