TY - JOUR
T1 - A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities
AU - Brian Jiang, Shang I.
AU - Kempers, Steven
AU - Rich, Phoebe
AU - Marcus, Stuart
AU - Houlihan, Anna
AU - Piacquadio, Daniel
AU - Pariser, David
N1 - Funding Information:
Acknowledgments The authors thank the patients and investigators who participated in this study. The authors also thank Mary Beth Ferdon for her contribution to statistical analysis and Michael Guttadauro for leading project management activities for this study. Administrative support for manuscript submission was provided by Denise Freeman of Therapeutics, Inc. and was funded by Sun Pharmaceutical Industries, Inc.
Funding Information:
Supported by DUSA Pharmaceuticals, Inc. The authors have indicated no significant interest with commercial supporters. S.I. Brian Jiang, S. Kempers, P. Rich, and D. Pariser were investigators on the actinic keratosis study presented in this article; S. Marcus and A. Houlihan were employed by DUSA Pharmaceuticals, Inc.; D. Piacquadio is employed by Therapeutics, Inc., the company providing CRO services.
Publisher Copyright:
© 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/7/1
Y1 - 2019/7/1
N2 - BACKGROUNDBlue-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.OBJECTIVETo prove the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the spot treatment of multiple AKs on upper extremities.METHODSAminolevulinic 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.RESULTSThirty-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.CONCLUSIONAminolevulinic acid-PDT spot treatment using a 3-hour occluded incubation was superior to VEH-PDT for AK lesion clearance of the upper extremity.
AB - BACKGROUNDBlue-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.OBJECTIVETo prove the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the spot treatment of multiple AKs on upper extremities.METHODSAminolevulinic 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.RESULTSThirty-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.CONCLUSIONAminolevulinic acid-PDT spot treatment using a 3-hour occluded incubation was superior to VEH-PDT for AK lesion clearance of the upper extremity.
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U2 - 10.1097/DSS.0000000000001760
DO - 10.1097/DSS.0000000000001760
M3 - Article
C2 - 30640777
AN - SCOPUS:85069180923
SN - 1076-0512
VL - 45
SP - 890
EP - 897
JO - Dermatologic Surgery
JF - Dermatologic Surgery
IS - 7
ER -