Distal Subungual Onychomycosis
Conditions
Keywords
Distal subungual onychomycosis
Brief summary
The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).
Interventions
DRUGTMI-358
Micro implant monthly x 3
DRUGMMI-467
Micro implant monthly x 3
Sponsors
Talima Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 to 75 years of age, inclusive * Diagnosed with distal subungual onychomycosis (DSO) of the toenails * Great toe(s) with intact skin and intact neurologic functions * Great toenail(s) free of nail polish * At least one target great toe which has: * 25 to 75% involvement of the area of the nail unit (including destroyed or missing parts of the nail plate) * at least 2 mm of uninvolved nail growth as measured from the proximal nail fold to the most proximal point to the disease process and with no lunular involvement * nail unit hyperkeratosis at the most distal edge which measures no greater than 3 mm * a positive KOH and culture
Exclusion criteria
* Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), immune systems, or other health conditions which could interfere with or confound the results of study assessments * Pre-existing chronic foot pain, neurologic deficit or skin disease/injury in treated foot * In the case of female subjects, are pregnant, nursing, or planning to become pregnant within the study period * History of clinically significant abnormal laboratory values, including liver function test results equal to or greater than 2 x the upper limit of normal * Disease-like psoriatic toenails, significant toenail abnormalities/dystrophies, toenail injuries or any other condition in the toenail which could interfere with study evaluations (e.g., prevent obtaining normal appearing nail, after clearing of onychomycosis, due to chemical damage, genetic or pigmentary disorders, etc.) * Have white superficial onychomycosis, proximal subungual onychomycosis, yellow spikes, or dermatophytoma * Have paronychia * Have a history of chronic alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rates | 48 weeks | Based on clinical evaluations (nail measurements, KOH, and mycological culture for dermatophytes), cure categories will be defined as either mycological cure, clinical cure, complete cure, or effective treatment. |
Countries
United States
Outcome results
None listed