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Safety and Efficacy of Next Science Gel on Toenail Fungus
Recruiting
Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.
What is being tested
- Next Science Treatment Gel (device)
Sponsor: Next Science TM · Participants: 20 · Started: Jul 26, 2019
Contact the study team
- Dianne Porral · Phone: 8555642762
Official record on ClinicalTrials.gov — NCT04042857
Locations in the U.S.
| Florida | Doctors Research Network, South Miami |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.