Anatomic Site-Specific Treatment Response With 40% Hydrogen Peroxide (w/w) Topical Formulation for Raised Seborrheic Keratoses: Pooled Analysis of Data from Two Phase 3 Studies.

OBJECTIVE: Seborrheic keratoses (SKs) may present in any non-glabrous skin, but data are limited on the response to treatment as based on the SK location. We aimed to understand the relationship between SK location and clearance with up to 2 treatments of 40% (w/w) hydrogen peroxide topical solution (HP40). METHODS: We conducted a sub-analysis of data pooled from two randomized, double-blind, vehicle (VEH)-controlled clinical trials, including 937 patients, each with 4 target SKs (N=3,748 SKs), with at least 1 on the face and 1 on the trunk or extremities. Treatment response was defined as 0 or 1 on a 4-point Physician's Lesion Assessment (PLA) scale (0=clear; 1=near-clear) after up to 2 applications, 3 weeks apart, and was assessed by SK location (face, trunk, and extremity). Local skin reactions were stratified by anatomic location and categorized based on immediate and delayed post-treatment reactions. Sensitivity analysis was conducted using the mean-per-patient (MPP) percent of SKs that are clear or near-clear at day 106. RESULTS: Treatment response was greater with HP40 versus VEH regardless of anatomic location of the SK. Clear or near-clear SKs with HP40 was observed in 65% of facial SKs (vs 10% VEH), 46% of truncal SKs (vs 5% VEH), and 38% of extremity SKs (vs 9% VEH). Facial SKs were more likely to be clear or near clear after a single treatment (43%), versus SKs on the trunk (31%) or extremities (14%). Most common immediate reactions with HP40 were erythema, stinging, and edema, which resolved to none or mostly mild within a week. Delayed reactions such as dyspigmentation and scarring occurred at low rates and were least reported for the facial SKs. CONCLUSIONS: SK clearance with HP40 was highest among SKs on the face and lowest among SKs on the extremities. Dyspigmentation rates were lowest among SKs treated on the face. Anatomic location of SK was a predictor of both treatment response and risk of dyspigmentation with HP40 application. ClinicalTrials.gov listings: NCT02667236 and NCT02667275 J Drugs Dermatol. 2018;17(10):1092-1098.

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302).

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.