Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Doctors Research Network
RECRUITING
South Miami
Contact Information
Primary
Dianne Porral
dporral@nextscience.com
8555642762
Time Frame
Start Date: 2019-07-26
Estimated Completion Date: 2021-10-01
Participants
Target number of participants: 20
Treatments
Experimental: Next Science
Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily.
Related Therapeutic Areas
Sponsors
Collaborators: NTS Ventures, Tissue Analytics, Doctors Research Network
Leads: Next Science TM