Background: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need.
Objective: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK).
Methods: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later.
Results: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106.
Limitations: The optimal number of treatment sessions was not evaluated.
Conclusion: Application of HP40 was well tolerated and effective in the removal of SKs.
Keywords: A-101; HP40; Physician's Lesion Assessment score; hydrogen peroxide; local skin reactions; seborrheic keratosis; topical solution.
Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.