Safety and Efficacy of Next Science Gel on Toenail Fungus
Next Science TM · with Doctors Research Network, Tissue Analytics · NCT04042857
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- July 26, 2019
- Record last updated
- August 2, 2019
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Next Science Treatment Gel
Conditions: Onychomycosis of Toenail
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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
Recruiting US locations
Doctors Research Network
South Miami, FL 33143
Site contact: Nara Clinical Research Network · 305-662-1444 · nneiva@miamifoot.com
Study contacts (from the official record)
- Dianne Porral · 8555642762 · dporral@nextscience.com