Treatment Satisfaction and Acceptability of 20% Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses of the Face, Scalp, and Upper Extremities

Daniel Piacquadio; Brian Berman; Daniel M Siegel; Neal Bhatia; Jason Brocato; Nicholas Squittieri; David M Pariser

Treatment Satisfaction and Acceptability of 20% Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses of the Face, Scalp, and Upper Extremities

J Clin Aesthet Dermatol. 2023 Dec;16(12):46-51.

Authors

Daniel Piacquadio¹, Brian Berman², Daniel M Siegel³, Neal Bhatia¹, Jason Brocato⁴, Nicholas Squittieri⁴, David M Pariser⁵

Affiliations

¹ Drs. Piacquadio and Bhatia are with Therapeutics, Inc., in San Diego, California.
² Dr. Berman is with Center for Clinical and Cosmetic Research in Aventura, Florida, and University of Miami Miller School of Medicine in Miami, Florida.
³ Dr. Siegel is with The State University of New York Downstate Health Sciences University in Brooklyn, New York, and Brooklyn Campus of the VA NY Harbor Healthcare System in Brooklyn, New York.
⁴ Drs. Brocato and Squittieri are with Sun Pharmaceutical Industries, Inc. in Princeton, New Jersey.
⁵ Dr. Pariser is with Eastern Virginia Medical School in Norfolk, Virginia, and Virginia Clinical Research, Inc. in Norfolk, Virginia.

PMID: 38125671
PMCID: PMC10729804

Abstract

Background: Actinic keratoses (AKs) are precancerous, dysplastic, epidermal lesions caused by chronic sun exposure that may progress to squamous cell carcinoma. Aminolevulinic acid 20% solution with blue light photodynamic therapy (ALA-PDT) has previously been shown to be superior to vehicle plus PDT (VEH-PDT) for treatment of AKs of the face, scalp, and upper extremities.

Objective: We report detailed patient satisfaction data for ALA-PDT.

Methods: Patient satisfaction for ALA-PDT versus VEH-PDT and patient-reported acceptability of ALA-PDT versus previous treatments for AKs were assessed in three randomized, vehicle-controlled studies (two Phase II and one Phase III) in adults. Patients in the Phase II studies were treated on the scalp and/or face, and those in the Phase III study were treated on the upper extremities.

Results: A total of 234, 166, and 269 patients were enrolled in the two Phase II studies and one Phase III study, respectively; overall, 79.8 percent of patients were male. Overall treatment satisfaction ranged from 79 to 88 percent for ALA-PDT, compared to 35 to 56 percent for VEH-PDT. Patients generally considered ALA-PDT to be equivalent to or more acceptable than prior treatments, including cryotherapy, 5-fluorouracil, imiquimod, previous PDT, and surgery. Similar proportions of patients receiving ALA-PDT or VEH-PDT on the upper extremities considered in-office time, side effects/adverse events (AEs), and duration of side effects/AEs to be acceptable.

Limitations: The majority of patients were male, and no statistical comparisons were conducted.

Conclusion: Patients were generally satisfied with ALA-PDT for the treatment of AKs of the face, scalp, and upper extremities and considered ALA-PDT to be equal to or more acceptable than previous treatments.

Trial registry information: ClinicalTrials.gov: NCT01475955; NCT02239679; NCT02137785.

Keywords: Photodynamic therapy; acceptability; actinic keratoses; aminolevulinic acid; treatment satisfaction.

Associated data

ClinicalTrials.gov/NCT02137785
ClinicalTrials.gov/NCT01475955
ClinicalTrials.gov/NCT02239679