A Study to Evaluate TMI-358 in the Treatment of Distal Subungual Onychomycosis

Study Overview
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Brief Summary
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The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).

Official Title
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A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TMI-358 in the Treatment of Distal Subungual Onychomycosis of the Toenail

Conditions
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Distal Subungual Onychomycosis

Intervention / Treatment
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* Drug: TMI-358
* Drug: MMI-467


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMI-358<br>Active treatment | Drug: TMI-358<br>* Micro implant monthly x 3<br>|
| Placebo Comparator: MMI-467<br> | Drug: MMI-467<br>* Micro implant monthly x 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rates | 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. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal subungual onychomycosis