Shang I Brian Jiang1, Steven Kempers2, Phoebe Rich3, Stuart Marcus4, Anna Houlihan5, Daniel Piacquadio6, David Pariser7. 1. Mohs and Dermatologic Surgery, University of California, San Diego, San Diego, California. 2. Department of Dermatology, Minnesota Clinical Study Center, University of Minnesota, Fridley, Minnesota. 3. Department of Dermatology, Oregon Dermatology and Research Center, Oregon Health and Science University, Portland, Oregon. 4. DUSA Pharmaceuticals, Inc., Wilmington, Massachusetts. 5. Clinical Research, DUSA Pharmaceuticals, Inc., Wilmington, Massachusetts. 6. Therapeutics, Inc., San Diego, California. 7. Department of Dermatology, Eastern Virginia Medical School, Virginia Clinical Research, Inc., Norfolk, Virginia.
Abstract
BACKGROUND:Blue-light aminolevulinic acid photodynamic therapy (ALA-PDT) after broad-area application and 3-hour incubation is efficacious for actinic keratosis (AK) lesion clearance on upper extremities, with use of occlusive dressing significantly increasing efficacy. OBJECTIVE: To prove the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the spot treatment of multiple AKs on upper extremities. METHODS:Aminolevulinic acid or VEH was spot applied only to lesions on one upper extremity 3 hours before blue-light exposure. Treated extremity was covered with occlusive dressing during incubation. Identical treatment was repeated at Week 8 if AK lesions were present in the treated area. RESULTS: Thirty-one percent (42/135) of subjects treated with ALA-PDT had complete clearance at Week 12, compared with 13% (17/134) of the subjects treated with VEH-PDT (p = .0001). The mean AK lesion clearance rate for ALA-treated subjects at Weeks 8 and 12 was 53% and 69%, respectively, compared with 26% and 30% for the VEH-treated group (p < .0001, linear mixed model). Safety profile observed in this study is consistent with previous studies/reports in the literature, and the therapy was well tolerated overall. CONCLUSION:Aminolevulinic acid-PDT spot treatment using a 3-hour occluded incubation was superior to VEH-PDT for AK lesion clearance of the upper extremity.
RCT Entities:
BACKGROUND: Blue-light aminolevulinic acid photodynamic therapy (ALA-PDT) after broad-area application and 3-hour incubation is efficacious for actinic keratosis (AK) lesion clearance on upper extremities, with use of occlusive dressing significantly increasing efficacy. OBJECTIVE: To prove the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the spot treatment of multiple AKs on upper extremities. METHODS:Aminolevulinic acid or VEH was spot applied only to lesions on one upper extremity 3 hours before blue-light exposure. Treated extremity was covered with occlusive dressing during incubation. Identical treatment was repeated at Week 8 if AK lesions were present in the treated area. RESULTS: Thirty-one percent (42/135) of subjects treated with ALA-PDT had complete clearance at Week 12, compared with 13% (17/134) of the subjects treated with VEH-PDT (p = .0001). The mean AK lesion clearance rate for ALA-treated subjects at Weeks 8 and 12 was 53% and 69%, respectively, compared with 26% and 30% for the VEH-treated group (p < .0001, linear mixed model). Safety profile observed in this study is consistent with previous studies/reports in the literature, and the therapy was well tolerated overall. CONCLUSION:Aminolevulinic acid-PDT spot treatment using a 3-hour occluded incubation was superior to VEH-PDT for AK lesion clearance of the upper extremity.
Authors: Nathalie C Zeitouni; Neal Bhatia; Roger I Ceilley; Joel L Cohen; James Q Del Rosso; Angela Y Moore; Gilly Munavalli; David M Pariser; Todd Schlesinger; Daniel M Siegel; Andrea Willey; Mitchel P Goldman Journal: J Clin Aesthet Dermatol Date: 2021-10