Recruiting

Next Science Gel

Sponsor:

Next Science TM

Code:

NCT04042857

Conditions

Onychomycosis of Toenail

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Next Science Treatment Gel

Study Details

Brief 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.

Conditions

Onychomycosis of Toenail

Study ID

NCT04042857

Start date

Jul 26, 2019

Status verified date

Jul, 2019

Completion date

Oct 1, 2021

Anticipated

Primary completion date

Oct 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Next Science

Patients will apply Next Science treatment to the study target hallux nail for 48 weeks daily.

Interventions

Next Science Treatment Gel

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

Primary outcome measure

  • Mycological Cure at 48 Weeks [ Time Frame: Baseline to 48 Weeks ]
  • Clinical Efficacy at 48 Weeks [ Time Frame: Baseline to 48 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Doctors Research Network

Recruiting

South Miami, Florida, United States, 33143

Contacts

Nara Clinical Research Network

305-662-1444nneiva@miamifoot.com

More Information

Sponsor

Next Science TM

Last update posted

Aug 2, 2019

Last verified

Jul, 2019

Keywords

  • DSO
  • toenail
  • onychomycosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Next Science TM on 2019-08-02.