Status:
RECRUITING
Safety and Efficacy of Next Science Gel on Toenail Fungus
Lead Sponsor:
Next Science TM
Collaborating Sponsors:
Doctors Research Network
Tissue Analytics
Conditions:
Onychomycosis of Toenail
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Patients will apply Next Science Wound Gel daily to each study treatment hallux nail for 48 weeks once approved for participation. Analysis will be attained via potassium hydroxide examination (KOH te...
Eligibility Criteria
Inclusion
- Ages 18 years old and above
- Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail
- Positive culture for dermatophytes and positive potassium hydroxide examination
- Provide signed and dated informed consent
- Willing to comply with all study procedures and available for the duration of the study
Exclusion
- Known allergic reaction to the study products
- Unable to provide signed and dated informed consent form
- Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study
- Thickness of mycotic nail is greater than 3mm
- Less than 2mm of clear nail at the proximal aspect
- History of rheumatoid arthritis
- Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis
- Unwilling or unable to limit use of nail polish for duration of study
- Known history of PVD, immune system concerns, or ongoing chemotherapy
- Severe moccasin tinea pedis
- Prior systemic antifungal drugs 6 months before study start date
- Prior topical therapy for toenail fungus 2 months before study start date
- Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
Key Trial Info
Start Date :
July 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04042857
Start Date
July 26 2019
End Date
October 1 2021
Last Update
August 2 2019
Active Locations (1)
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1
Doctors Research Network
South Miami, Florida, United States, 33143