A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities

Shang I. Brian Jiang, Steven Kempers, Phoebe Rich, Stuart Marcus, Anna Houlihan, Daniel Piacquadio, David Pariser

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)890-897
Number of pages8
JournalDermatologic Surgery
Volume45
Issue number7
DOIs
StatePublished - Jul 1 2019

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Actinic Keratosis
Aminolevulinic Acid
Photochemotherapy
Upper Extremity
Occlusive Dressings
Safety
Light
Acids
Therapeutics
Linear Models
Extremities
1-phenyl-3,3-dimethyltriazene

ASJC Scopus subject areas

  • Surgery
  • Dermatology

Cite this

A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities. / Brian Jiang, Shang I.; Kempers, Steven; Rich, Phoebe; Marcus, Stuart; Houlihan, Anna; Piacquadio, Daniel; Pariser, David.

In: Dermatologic Surgery, Vol. 45, No. 7, 01.07.2019, p. 890-897.

Research output: Contribution to journalArticle

Brian Jiang, Shang I. ; Kempers, Steven ; Rich, Phoebe ; Marcus, Stuart ; Houlihan, Anna ; Piacquadio, Daniel ; Pariser, David. / A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities. In: Dermatologic Surgery. 2019 ; Vol. 45, No. 7. pp. 890-897.
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abstract = "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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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.

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