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Clinical Trials in the USA / NCT04042857
Recruiting Not applicable

Safety and Efficacy of Next Science Gel on Toenail Fungus

NCT04042857 · tracked via the Priya Life Science USA tracker
Sponsor
Next Science TM
Phase
Not applicable
Started
2019-07-26
Last updated
2019-08-02

Condition(s) studied

Onychomycosis of Toenail

Investigational drug(s) / intervention(s)

Next Science Treatment Gel

Next Science Treatment Gel: Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Doctors Research Network South Miami Florida Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04042857 on ClinicalTrials.gov ↗ ← All trials in the USA