Application of hydrogen peroxide topical solution 40% (HP40) is an effective treatment for seborrheic keratoses (SKs) of the face, trunk, and extremities, with a low risk of inducing scarring and pigmentary changes, according to the results of 2 identically designed, randomized, double-blind, placebo-controlled, phase 3 studies (ClinicalTrials.gov Identifiers: NCT02667236 and NCT02667275) that were published in the Journal of the American Academy of Dermatology.
The investigators sought to evaluate the efficacy and safety of HP40 vs vehicle (VEH) for the treatment of SKs. A total of 937 patients with 4 SKs (≥1 lesion each on the face and trunk/extremities) were randomly assigned in a 1:1 ratio to HP40 or VEH. Overall, 450 patients were enrolled in study 1 (HP40: n=223; VEH: n=227), and 487 patients were enrolled in study 2 (HP40: n=244; VEH: n=243).
At each visit, SKs were graded via use of the Physician’s Lesion Assessment (PLA) scale
(0: clear; 1: near-clear; 2: ≤1 mm thick; 3: >1 mm thick). After 1 treatment, all SKs with a PLA score >0 were retreated 3 weeks later.
At day 106, significantly more patients treated with HP40 compared with patients treated with VEH attained complete clearance (ie, a PLA score of 0) on all 4 SKs (study 1: 4% [9 of 223] vs 0% [0 of 227], respectively; study 2: 8% [19 of 244] vs 0% [0 of 243], respectively; P <.01 for both) and complete clearance on 3 of 4 SKs (study 1: 13% [30 of 223] vs 0% [0 of 227], respectively; study 2: 23% [56 of 244] vs 0% [0 of 243], respectively; P <.0001 for both).
A higher mean per-patient percentage of SKs treated with HP40 vs VEH were deemed clear (study 1: 25% vs 2%, respectively; study 2: 34% vs 1%, respectively) or clear/near-clear (study 1: 47% vs 10%, respectively; study 2: 54% vs 5%, respectively). Local skin reactions were mostly mild and resolved by day 106.
The investigators concluded that application of HP40 was well tolerated and associated with resolution of SKs. A major limitation of the study was the fact that the optimal number of treatment sessions needed was not evaluated.
Baumann LS, Blauvelt A, Draelos ZD, et al. Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w) in patients with seborrheic keratoses: results from two identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302) [published online June 1, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.05.044