Title: Long-Term Efficacy and Safety of Hydrogen Peroxide Topical Solution, 45% (w/w) in Patients With Common Warts: Posttreatment Results From the Phase 2 WART‑203 Trial
Background: Verruca vulgaris (common warts) is a cutaneous manifestation of the human papillomavirus with no FDA-approved prescription therapies available. We evaluated the long-term efficacy and safety of the proprietary, stabilized hydrogen peroxide topical solution, 45% (w/w) (HP45) in patients with common warts at 12 weeks after treatment completion.
Methods: The Phase 2 WART-203 trial (NCT03278028) was designed to evaluate the efficacy and safety of twice-weekly HP45 administration vs vehicle for 8 weeks in patients with common warts. Eligible patients were aged ≥8 years and had 1 to 6 warts (1 target wart) on the trunk or extremities with a Physician’s Wart AssessmentTM (PWA) grade ≥2 (range, 0 [clear] to 3 [wart ≥6 mm in diameter]). Efficacy assessments in the per-protocol population at 12 weeks after the last treatment (week 20) for HP45 vs vehicle were the mean change from baseline in target wart PWA grade, proportions of patients with target wart clear and all treated warts clear, and mean per-patient percentages of treated warts clear. Statistical significance was defined as a=0.05. Safety assessments included adverse events (AEs).
Results: Of 159 patients enrolled and treated, 157 patients were included in the per-protocol population, and 151 patients completed posttreatment week 20 (HP45, n=75; vehicle, n=76). Patients treated with HP45 maintained a significantly greater reduction in mean target wart PWA grade from baseline (–1.00) at week 20 vs those treated with vehicle (–0.39; P=0.0004). Mean PWA grades at week 20 were 1.4 and 2.0 for HP45 and vehicle, respectively. Proportions of patients with target wart clear at week 20 remained significantly greater for HP45 treatment (37.3%) vs vehicle (11.8%; P=0.0002). A significantly greater proportion of patients in the HP45 group maintained all treated warts clear at week 20 (33.3%) vs those in the vehicle group (7.9%; P=0.0002). The mean per-patient percentage of treated warts clear at week 20 remained significantly greater for HP45 (39.8%) vs vehicle (13.3%; P=0.0001). Of 159 patients in the safety analysis, 47 patients reported 76 AEs; most were mild or moderate in severity. No serious AEs or discontinuations due to AEs were observed.
Conclusions: Safety and clinical efficacy findings observed at 8 weeks of treatment with HP45 were maintained for 12 weeks following treatment cessation in patients with common warts. A confirmatory Phase 3 clinical program is underway.