Treatment of toenail fungus with Next Science Gel
Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
This study is testing if a new gel can safely and effectively treat toenail fungus in people with mild to moderate cases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Next Science TM Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (South Miami, Florida) |
| Trial ID | NCT04042857 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is relatively novel, previous studies on topical treatments for onychomycosis have shown varying degrees of success.
Eligibility criteria
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 this trial is running
South Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.