Safety and Efficacy of Next Science Gel on Toenail Fungus

Description

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.

Conditions

Onychomycosis of Toenail

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Study Overview

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Study Details

Study overview

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.

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

Safety and Efficacy of Next Science Gel on Toenail Fungus

Condition
Onychomycosis of Toenail
Intervention / Treatment

-

Contacts and Locations

South Miami

Doctors Research Network, South Miami, Florida, United States, 33143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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/or unavailable for duration of the study
  • 4. Thickness of mycotic nail is greater than 3mm
  • 5. Less than 2mm of clear nail at the proximal aspect
  • 6. History of rheumatoid arthritis
  • 7. Subject with any other disease or condition other than DSO that would affect nail appearance or interfere with image analysis
  • 8. Unwilling or unable to limit use of nail polish for duration of study
  • 9. Known history of PVD, immune system concerns, or ongoing chemotherapy
  • 10. Severe moccasin tinea pedis
  • 11. Prior systemic antifungal drugs 6 months before study start date
  • 12. Prior topical therapy for toenail fungus 2 months before study start date
  • 13. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Next Science TM,

Maria S Surprenant, DPM, PRINCIPAL_INVESTIGATOR, Doctors Research Network

Study Record Dates

2021-10-01