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A-101 Demonstrated Efficacy in SK Treatment of Face

Dermatol Surg; ePub 2017 Sep 4; DuBois, et al

A-101 solution demonstrated efficacy in treating seborrheic keratosis (SK) on the face, a recent study found. Although greater magnitude of effect was seen with the 40% concentration than the 32.5% concentration, A-101 solution had a favorable safety and tolerability profile at both concentrations. In this multicenter, double-blind, vehicle-controlled study, eligible subjects were randomly assigned to receive up to 2 treatments of A-101 40%, A-101 32.5%, or vehicle solution applied to a single facial SK lesion. The primary efficacy assessment was the Physician's Lesion Assessment (PLA), a validated 4-ordinal scale. Investigators found:

  • The primary end point, the mean reduction in PLA grade from baseline to Day 106 was 1.7 for A-101 40%, 1.4 for A-101 32.5%, and 0.1 for vehicle.
  • Lesions for 68%, 62%, and 5% of subjects, respectively, were judged to be clear or near clear.
  • Local skin reactions were predominantly mild and transient; no subjects discontinued because of treatment-related adverse events.

Citation:

DuBois JC, Jarratt M, Beger BB, Bradshaw M, Powala CV, Shanler SD. A-101, a proprietary topical formulation of high-concentration hydrogen peroxide solution: A randomized, double-blind, vehicle-controlled, parallel group study of the dose-response profile in subjects with seborrheic keratosis of the face. [Published online ahead of print September 4, 2017]. Dermatol Surg. doi:10.1097/DSS.0000000000001302.

Commentary:

While we have several modalities that are used to remove seborrheic keratoses, these techniques are all associated with risks of pain, scarring, and pigmentary alterations. When it comes to removing these lesions, there is a need for novel methods with improved efficacy, safety, and tolerability profiles. A-101, a proprietary topical formulation of high-concentration hydrogen peroxide solution, has demonstrated these qualities in clinical trials performed to date. This medication will offer a non-invasive, in-office treatment administered by physicians or other licensed health care professionals. A-101 has been the focus of a robust clinical development program in which more than 700 patients have been treated. —Jeffrey M. Weinberg, MD