A Novel Topical Nitric Oxide Releasing Gel Demonstrates Effective Nail Penetration and Potent Antifungal Activity in Onychomycosis
Bibliographic record
Abstract
Introduction: Onychomycosis remains a difficult-to-treat fungal infection due to nail plate impermeability, high recurrence, and limited efficacy of topical agents. Systemic antifungals are effective but constrained by safety and drug interaction concerns. Nitric oxide (NO), a small antimicrobial molecule, may overcome these barriers through superior penetration and broad fungicidal activity. Aim: To evaluate the nail penetration, antifungal efficacy, and early clinical potential of a nitric oxide–releasing gel (NORS-Gel) in onychomycosis. Methods: Ex vivo human nail models were used to assess NORS-Gel penetration and antifungal activity with colorimetric, immunohistochemical, and microbiological assays. Comparative assays with terbinafine were conducted. Two patients with culture-confirmed or clinically diagnosed onychomycosis applied NORS-Gel daily for 4–6 weeks, with safety and early outcomes recorded. Results: NORS-Gel fully penetrated the nail plate, confirmed by s-nitrosothiol accumulation and nail discoloration. Fungal burden assays showed complete eradication of Trichophyton mentagrophytes (0 CFU/g) versus terbinafine (3.58 ± 0.2 log₁₀ CFU/g). In an ex vivo infection model, NORS-Gel achieved full clearance within 14 days, sustained through Day 30, with no regrowth during 21-day post-treatment incubation. In observational human cases, NORS-Gel was well tolerated, with only transient nail discoloration and occasional mild local irritation. Non-great toenails showed early evidence of healthy regrowth; follow-up was insufficient to confirm great toenail outcomes. Conclusions: NORS-Gel achieves rapid and complete nail penetration and demonstrates potent fungicidal activity in ex vivo models. Early clinical experience supports its safety and potential efficacy. Controlled clinical trials are warranted to validate findings and establish treatment protocols. 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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".