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

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.

Informations de copyright

Copyright © 2023. Matrix Medical Communications. All rights reserved.

Déclaration de conflit d'intérêts

DISCLOSURES: DP is an employee of Therapeutics, Inc. BB has received grants and consulting fees from Almirall; Biofrontera; Bristol Myers Squibb; DUSA Pharmacuticals, Inc.; Evoimmune; Mediwound; MINO Labs; Pfizer; and Sun Pharmaceutical Industries, Inc. DS has received honoraria and/or consultant fees and/or investigator grants/research funding from Avita; Biofrontera AG; Cara Therapeutics; DermaSensor, Inc.; Medforce Technologies, Inc.; MedX Health; Pulse Biosciences; Regeneron; Sanofi Genzyme; SciBASE; Sol-Gel Technologies; Strata Skin Sciences; UCB; and Verrica Pharmaceuticals, Inc.; and may own stock and/or stock options in Biofrontera AG; Greenway Therapeutix, Inc.; Logical Images; Modernizing Medicine; Novascan; Or-Genix Therapeutics; Palmm; Plasmend; RaMedical; Seaspire Skincare; SkinVision; and Tetros Group. NB is an advisor, consultant, and investigator for AbbVie; Almirall; Arcutis; Beiersdorf; Biofrontera; Bristol Myers Squibb; Boehringer Ingelheim; Cara; Dermavant; Eli Lilly; EPI Health; Ferndale; Galderma; InCyte; ISDIN; Johnson & Johnson; LaRoche-Posay; LEO Pharma; Ortho Dermatologics; Pfizer; Regeneron; Sanofi; Sun Pharmaceutical Industries, Inc.; and Verrica Pharmaceuticals, Inc. JB and NS are employees of Sun Pharmaceutical Industries, Inc. DMP has received honoraria and grants or research funding as a consultant, advisory board participant, or investigator from Bickel Biotechnology, Dermira, LEO Pharma US, Novartis, Pfizer, and Regeneron; honoraria as a consultant or data monitoring board participant from Biofrontera AG, Bristol Myers Squibb, and Sanofi; and grants or research funding as an investigator from Almirall; Amgen; AOBiome, LLC; Asana Biosciences, LLC; Celgene; Eli Lilly; Menlo Therapeutics; Novo Nordisk A/S; and Ortho Dermatologics.