Efficacy and safety of a topical nitric oxide-releasing solution (NORS) as a noninvasive treatment for plantar warts (verrucae plantaris).

BACKGROUND

Plantar warts (verrucae plantaris), caused by human papillomavirus, are common and often resistant to standard therapies, which can be painful and damaging. Novel, noninvasive options are needed.

OBJECTIVE

To evaluate the safety and preliminary efficacy of a topical nitric oxide-releasing solution (NORS) as a self-administered therapy for plantar warts.

METHODS

In this Phase 2a, multicenter, randomized, double-blind, placebo-controlled trial, 20 participants with ≥3 plantar warts were randomized (1:1:1) to NORS 1X (41.1 PPM·min), NORS 3X (121.9 PPM·min), or placebo. Participants completed 15-minute footbaths three times weekly for 3 weeks, followed by 2 weeks of observation. The primary endpoint was complete wart clearance at Day 35; secondary endpoints included ≥70% wart area reduction, pain change, and Physician Wart Assessment (PWA) grading.

RESULTS

NORS was well tolerated with no serious adverse events; mild, transient irritation occurred in 85% of participants. Complete clearance was achieved in 6% (NORS 1X), 8% (NORS 3X), and 0% (placebo). A ≥ 70% wart area reduction occurred in 21%, 16%, and 12%, respectively. Pain improvement and a 50% reduction in severe warts (PWA grade 3) were observed only with NORS 3X.

CONCLUSION

NORS demonstrated favorable safety and early clinical activity, warranting larger, longer-term efficacy trials.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05877313.