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RecruitingNot ApplicableNCT04042857

Safety and Efficacy of Next Science Gel on Toenail Fungus

Safety and Efficacy of Next Science Wound Gel in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO): An Open-Label Pilot Study

Sponsor

Next Science TM

Enrollment

20 participants

Start Date

Jul 26, 2019

Study Type

INTERVENTIONAL

Conditions

Onychomycosis of Toenail

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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

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Interventions

DEVICENext Science Treatment Gel

Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.

Locations(1)

Doctors Research Network

South Miami, Florida, United States

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NCT04042857