Treatment of toenail fungus with Next Science Gel
Official title: Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
Run by Next Science TM · NCT04042857 · Data updated 2026-11-12
This study is testing if a new gel can safely and effectively treat toenail fungus in people with mild to moderate cases.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Next Science TM Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (South Miami, Florida) |
| Status | Recruiting |
| Started | July 26, 2019 |
| Main results expected | October 1, 2020 |
| Study ends | October 1, 2021 |
| Registry record updated | August 2, 2019 |
| Trial ID | NCT04042857 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a confirmed diagnosis of distal subungual onychomycosis affecting 20-75% of their hallux nail.
✕Probably not a fit
Patients with severe nail thickness, other conditions affecting nail appearance, or known allergies to the study products may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a 52-week open-label pilot study evaluating the safety and efficacy of Next Science Wound Gel for treating mild to moderate distal subungual onychomycosis. Participants will apply the gel daily to their affected hallux nail, with assessments conducted through potassium hydroxide examinations, nail cultures, PCR analysis, and photographic imaging. Eligible patients must have a confirmed diagnosis and will be monitored through multiple in-clinic visits over the study duration. If patients achieve a complete cure before the 48-week mark, they will be encouraged to continue treatment for the full study period.
Why it matters
Potential benefit: If successful, this treatment could provide an effective topical option for patients suffering from toenail fungus.
How similar studies have gone: While this approach is relatively novel, previous studies on topical treatments for onychomycosis have shown varying degrees of success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages 18 years old and above 2. Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail 3. Positive culture for dermatophytes and positive potassium hydroxide examination 4. Provide signed and dated informed consent 5. Willing to comply with all study procedures and available for the duration of the study Exclusion Criteria: 1. Known allergic reaction to the study products 2. Unable to provide signed and dated informed consent form 3. Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study 4. Thickness of mycotic nail is greater than 3mm 5. Less than 2mm of clear nail at the proximal aspect 6. History of rheumatoid arthritis 7. Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis 8. Unwilling or unable to limit use of nail polish for duration of study 9. Known history of PVD, immune system concerns, or ongoing chemotherapy 10. Severe moccasin tinea pedis 11. Prior systemic antifungal drugs 6 months before study start date 12. Prior topical therapy for toenail fungus 2 months before study start date 13. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
Where it's running
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Doctors Research Network
South Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Maria S Surprenant, DPM — Doctors Research Network
- Study coordinator: Dianne Porral
- Email: dporral@nextscience.com
- Phone: 8555642762
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Topical Filmogel for toenail fungus
The study tests URGO MICKAEL Filmogel as a daily topical treatment for mild to moderate toenail fungus in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.