Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

Study Overview
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Brief Summary
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The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults

Conditions
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Onychomycosis of Toenails

Intervention / Treatment
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* Drug: AN2690 Topical Solution, 5%
* Drug: Solution Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail KOH positive at screening Willingness not to use any other products including nail polish applied to the toenails during the study Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period Exclusion Criteria: Concurrent or recent use of certain topical or systemic medications without a sufficient washout period History of any significant chronic fungal disease other than onychomycosis Significant confounding conditions as assessed by study doctor Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AN2690 Topical Solution, 5%<br>AN2690 Topical Solution, 5% | Drug: AN2690 Topical Solution, 5%<br>* AN2690 Topical Solution, 5%, applied once daily for 48 weeks<br>|
| Placebo Comparator: Solution Vehicle<br>Solution Vehicle | Drug: Solution Vehicle<br>* AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completely Clear or Almost Clear Target Great Toenail at Week 52 | No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis. | Week 52 | 
| Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture. | Week 52 | 
| Negative Mycology of Target Great Toenail at Week 52 | Negative KOH and negative fungal culture. | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis, nail fungus, toenail fungus, fungal nail, hyperkeratosis, nail infection, nail treatment, toenail infection, toenail treatment, foot dermatoses, fungal culture, onycholysis, podiatrist, podiatry, subungual, tinea unguium, antifungal, anti-fungal, dermatologist, dermatology, dermatophyte, distal subungual onychomycosis, yellow nail, thick nail, brittle nail, crumbling nail, discolored nail, weak nail