Hydrogen Peroxide Topical Solution, 45% For Common Warts: Phase 2 Efficacy And Safety Trial Results

Background: No FDA-approved prescription therapies are available for common warts.Objective: We evaluated a proprietary hydrogen peroxide topical solution, 45% (w/w) (HP45) for treatment of common warts.Methods: In the phase 2 randomized, double-blind, vehicle-controlled WART-203 trial (NCT03278028), eligible patients aged years had 1-6 warts (1 target wart) on the trunk or extremities with a Physician's Wart Assessment (TM) (PWA) grade >= 2 (range, 0 [clear) to 3 [wart 3-8 mm in diameter or length)). Patients self-administered HP45 or vehicle twice weekly for 8 weeks and were evaluated through 12 weeks posttreatment (week 20). Efficacy assessments included mean change in target wart PWA grade from baseline at week 8 (primary endpoint) and proportions of patients with target wart clearance. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs).Results: A total of 157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76). A significantly greater reduction in mean target wart PWA grade from baseline at week 8 was achieved with HP45 (-0.87) vs vehicle (-0.17; P<0.0001) and maintained at week 20 (-1.00 vs 0.39; P=0.0004). The proportion of patients with target wart clearance at week 8 was significantly greater with HP45 (25.3%) vs vehicle (2.6%; P<0.0001) and remained significantly greater at week 20 (37.3% vs 11.8%; P=0.0002). Forty-seven patients reported 76TEAEs; most were mild or moderate in severity. Most LSRs were mild and resolved by week 20. In pediatric patients (HP45, n=13; vehicle, n=6), greater reductions in mean target wart PWA grade from baseline were observed with HP45 vs vehicle at weeks 8 (-1.0 vs 0) and 20 (-1.2 vs 0.5).Conclusion: These findings support the efficacy and safety of HP45 for the treatment of common warts in patients >= 8 years of age.