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Hydrogen Peroxide Topical Solution for Common Warts
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In this clinical trial, 157 patients (age >8 years) with 1 to 6 warts measuring 3 to 8 mm were treated with twice-weekly application of hydrogen peroxide 45% (HP45, n=79) or vehicle (n=78) for 8 weeks. Nearly one-quarter of patients experienced clearance of target wart by 8 weeks (vs 2.6% with vehicle), and at week 20 follow-up, clearance was seen in 37.3% with HP45 (vs 11.8% with placebo), indicating that there may be a continued response after stopping treatment at 8 weeks. There were 76 treatment-emergent adverse events in the HP45 group, all of which were mild or moderate, and none led to treatment discontinuation.
- These data support the efficacy and safety of an 8-week biweekly application of hydrogen peroxide 45% solution for treatment of common warts.
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 ≥8 years had 1–6 warts (1 target wart) on the trunk or extremities with a Physician's Wart Assessment™ (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 76 TEAEs; 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. J Drugs Dermatol. 2020;19(10):969-976. doi:10.36849/JDD.2020.5054.
Journal of Drugs in Dermatology
Hydrogen Peroxide Topical Solution, 45% for Common Warts: Phase 2 Efficacy and Safety Trial Results
J Drugs Dermatol 2020 Oct 01;19(10)969-976, SR Smith, SK Trying, KK Grande, J Schlessinger, MH Gold, SD Shanier
Skin Care Physicians of Costa Rica
Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574
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