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

October 2020 | Volume 19 | Issue 10 | 969 | Copyright © October 2020


Published online September 16, 2020

doi:10.36849/JDD.2020.5054

Stacy R. Smith MD,a Stephen K. Tyring MD PhD,b Kimberly K. Grande MD,c Joel Schlessinger MD,d Michael H. Gold MD,e Stuart D. Shanler MD FAAD FACMSf

aCalifornia Dermatology & Clinical Research Institute, Encinitas, CA bDepartment of Dermatology, Center for Clinical Studies, University of Texas Health Science Center, Houston, TX cThe Skin Wellness Center, Knoxville, TN dSkin Specialists, PC, Omaha, NE eTennessee Clinical Research Center, Nashville, TN fAclaris Therapeutics, Inc., Wayne, PA

Abstract
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

INTRODUCTION

Common warts, also known as verruca vulgaris, are benign skin and mucosal growths caused by human papillomavirus (HPV) infection of keratinocytes.1 Common warts can occur at virtually any anatomic location, but typically occur on the fingers, hands, and sites prone to trauma (eg, knees, elbows).2 In immunocompetent individuals, cutaneous warts may spontaneously resolve; however, they often persist for years, may spread to distant anatomic regions by autoinoculation, and may be painful.1-3 Approximately 10% of the population is affected by warts, and common warts account for 70% of this prevalence.4,5 Common warts are more prevalent in children, especially adolescents, affecting 10% to 20% of school-aged children, typically those aged 12–16 years.5

No specific antiviral therapies are available to treat cutaneous HPV infection, and no US Food and Drug Administration–approved prescription treatment is available for cutaneous common warts. Many therapies provided by health care practitioners involve the off-label use of drugs approved for other indications, the safety and/or efficacy of which is unproven for treating common warts. These therapies employ locally destructive or ablative modalities to treat lesions, and include cryotherapy with liquid nitrogen or another cryogen, electrosurgery, curettage, application of acids (eg, salicylic acid, trichloroacetic acid) or blistering agents, locally cytotoxic therapies, and topical immunotherapy or immunomodulatory agents.2,6,7 Several of these are available in over-the-counter formulations with lower concentrations than those used in the office setting.2 While sometimes effective, many are painful and may necessitate anesthesia and/or analgesia. Moreover, some procedures can be complicated by adverse cosmetic outcomes like scarring and infection. No single therapy is consistently
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