Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail.

Detailed Description
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The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 5% AN2690 Solution.

Official Title
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An Open Label, Multi-center Study To Evaluate The Safety And Efficacy Of Topically Applied An2690 1% And 5% Solutions For The Treatment Of Adult Subjects With Onychomycosis Of The Great Toenail

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: AN2690
* Drug: AN2690


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee A signed Health Insurance Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information for those enrolled in the United States of America Male or female subjects of any race 18 -65 years of age Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount and a positive fungal culture for dermatophyte species Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day1) by visual inspection after the nail has been trimmed The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth Exclusion Criteria: Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study Subjects with chronic moccasin type of T. pedis Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis Diabetes mellitus requiring treatment other than diet and exercise Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications: Topical antifungal applied to toenails (does not include antifungals for treatment of T. pedis): 12 weeks Anti-inflammatories, corticosteroids, topical immunomodulators (in the treatment area): 2 weeks Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications: Corticosteroids (including intramuscular injections): 2 weeks Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte species: 24 weeks Systemic immunomodulators: 4 weeks Treatment of any type for cancer within the last 6 months History of any significant internal disease Subjects with a medical history of current or past psoriasis of the skin and/or nails Concurrent lichen planus Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated AIDS or AIDS related complex History of street drug or alcohol abuse Any subject not able to meet the study attendance requirements Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group/Cohort 1<br>AN2690 1% Solution (30 subjects) | Drug: AN2690<br>* AN2690 1% Solution, once daily for 180 days<br>|
| Experimental: Group/Cohort 2<br>AN2690 5% Solution (30 subjects) | Drug: AN2690<br>* AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete or partial clinical evidence of great toenail clearance or at least 2 mm of fungal clear linear great toenail growth plus a negative fungal culture from the treatment targeted toenail at the End-of-treatment (Day 180) |  | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluations of mycological response, changes from baseline linear toenail growth, proportion of subjects who are successful Complete Responders |  | Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis, Fungal Nail