Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
Next Science TM
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.
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 test), nail culture, PCR analysis, and photographic imaging. Subjects may have both hallux nails sampled at screening for culture and KOH testing if both hallux nails appear to meet the criteria for study inclusion. Only subjects with both a positive culture and KOH examination will start study treatment. Subjects may have repeat KOH and culture testing both performed if the first screening test res…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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/o…
Interventions
- DeviceNext Science Treatment Gel
Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
Location
- Doctors Research NetworkSouth Miami, Florida