Phase 2a Randomized, Double-Blinded, Placebo-Controlled Trial of a Topical Nitric Oxide Releasing Solution (NORS) for the Treatment of Plantar Warts (HPV-Warts-01)
Bibliographic record
Abstract
Background: Verrucae plantaris (plantar warts) are common cutaneous lesions of the plantar aspect of the foot that are caused by the human papillomavirus (HPV) infection of keratinocytes. When plantar warts cause pain, they may alter patient’s normal posture or gait, occasionally without them realizing it. Nitric oxide has known antimicrobial, antiviral, and immunomodulatory properties. NORS (nitric oxide releasing solution) was evaluated for safety and efficacy in participants with multiple plantar warts. Standard approaches such as salicylic acid and surgical removal can be uncomfortable for patients, slow to act, and still have wart recurrence. Nitric oxide is an endogenous signaling molecule with multimodal effects, including disruption of viral replication, interference with host cell entry, and enhancement of local immune activity. A nitric oxide releasing solution (NORS) in the form of a soak provides a noninvasive treatment strategy that may overcome the limitations of current therapies. This phase 2a study evaluated the safety and efficacy of NORS in participants with multiple plantar warts. Methods: This multicenter, randomized, double-blinded, placebo-controlled phase 2a trial (HPV-Warts-01; NCT05877313) enrolled 20 participants with ≥3 plantar warts. Participants were randomized 1:1:1 to NORS 1X (41.1 PPM*min), NORS 3X (121.9 PPM*min), or placebo (sterile water). Treatment consisted of a self-administered foot bath (500 mL for 15 minutes) three times weekly for three weeks. The primary endpoint was complete wart clearance at Day 35, measured by photographic assessment. Secondary endpoints included reduction in wart area size, pain reduction reported by participants, and safety. Results: Twenty participants (70% male; mean age 49 years) with 116 warts were randomized: NORS 1X (n=6, 33 warts), NORS 3X (n=8, 50 warts), and placebo (n=6, 33 warts). Six HPV genotypes were detected; HPV2, HPV27, and HPV57 predominated. Complete wart clearance was observed in 6% of warts in the 1X arm, 8% in the 3X arm, and 0% in placebo. At least 70% reduction in wart area occurred in 21% (NORS 1X), 16% (NORS 3X), and 12% (placebo). Pain scores improved only in the NORS 3X arm (mean change –0.8). Treatment was generally well tolerated; most adverse events (AEs) were mild, including skin discoloration, dryness, and blistering. No severe or serious AEs occurred. Conclusions: NORS demonstrated a favorable safety profile and a trend toward wart clearance and pain reduction. More frequent or prolonged dosing may be necessary. Future studies will evaluate optimized dosing schedules in younger populations with less chronic disease burden. Whereas conventional therapies can frequently cause pain, tissue damage, or scarring, NORS offered a painless and noninvasive soak that participants could self-administer, underscoring its potential as a safer and more comfortable alternative to conventional wart therapies. Sponsored: SaNOtize Research and Development Corporation
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.013 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".