Topical Gel Anti-Fungal Agent for Tinea Unguium

Study Overview
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Brief Summary
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The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis). The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety. Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.

Official Title
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Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: Organogel of naftifine, 2%
* Drug: Organogel of terbinafine, 2%
* Drug: Organogel of naftifine, 6%
* Drug: Organogel of terbinafine, 6%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of distal subungual tinuea unguium of one great toenail. between 20 - 65% infected area for target nail 2 mm of clear nail proximally on target nail positive dermatophyte culture and positive KOH test able to sign informed consent understand requirements of study females must be post-menopausal or agree to use approved contraceptives throughout the study Exclusion Criteria: patients with nails infected with organisms other than dermatophytes patients with proximal subungual tinea unguium patients with spikes of disease extending to nail matrix patients with more than 5 infected nails patients with confounding problems/ abnormalities of target nail patients with screening lab values more than 20% of normal patients with known hypersensitivity to test material components patients requiring systemic medications that may interfere with study patients with a poor history of compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Organogel of naftifine, 2%|nan|
|Drug: Organogel of terbinafine, 2%|nan|
|Drug: Organogel of naftifine, 6%|nan|
|Drug: Organogel of terbinafine, 6%|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quanitative improvement in toenail appearance. |  |  | 
| Assessment of dermatophyte culture and KOH examination. |  |  | 
| Frequency and severity of adverse events. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve 90% and 100% clearance of fungus from nail. |  |  | 
| Assessment of treatment success. |  |  | 
| Assessment of mycological success. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinea unguium, onychomycosis