RecruitingNot Applicable

Safety and Efficacy of Next Science Gel on Toenail Fungus

United States20 participantsStarted 2019-07-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Mycological Cure at 48 Weeks

Timeframe: Baseline to 48 Weeks

Clinical Efficacy at 48 Weeks

Timeframe: Baseline to 48 Weeks

Trial details

NCT IDNCT04042857

SponsorNext Science TM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-01

Contact for this trial

Dianne Porral

8555642762 dporral@nextscience.com

View on ClinicalTrials.gov More Onychomycosis of Toenail trials