Actively Recruiting
Safety and Efficacy of Next Science Gel on Toenail Fungus
Led by Next Science TM · Updated on 2019-08-02
20
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
N
Next Science TM
Lead Sponsor
D
Doctors Research Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Next Science Gel on Toenail Fungus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 years old and above
- Established and active diagnosis of distal subungual onychomycosis affecting 20-75% of at least one big toenail
- Positive fungal culture and positive potassium hydroxide examination
- Signed and dated informed consent provided
- Willing to comply with all study procedures and available for study duration
You will not qualify if you...
- Known allergy to the study products
- Unable to provide signed and dated informed consent
- Unable or unwilling to comply with study procedures or unavailable for study duration
- Mycotic nail thickness greater than 3 mm
- Less than 2 mm of clear nail at the nail base
- History of rheumatoid arthritis
- Other diseases affecting nail appearance or interfering with analysis
- Unwilling or unable to limit use of nail polish during the study
- History of peripheral vascular disease, immune system problems, or ongoing chemotherapy
- Severe moccasin tinea pedis
- Use of systemic antifungal drugs within 6 months before study
- Use of topical toenail fungus treatments within 2 months before study
- Any condition that investigator believes prevents safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Doctors Research Network
South Miami, Florida, United States, 33143
Actively Recruiting
Research Team
D
Dianne Porral
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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