Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

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 5.0% and 7.5% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

Detailed Description
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The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 5% AN2690 Solution. Provided that there is adequate evidence of clinical safety after two weeks of dosing with 5% AN2690 Solution, a second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 7.5% AN2690 Solution. A third group of 30 subjects will be enrolled and assigned the highest safe concentration of AN2690 evaluated in this study.

Official Title
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An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution 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 Solution, 5.0%
* Drug: AN2690 Solution, 7.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Witnessed, signed informed consent approved by Ethics Committee Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail Onychomycosis involving 20-60% of the affected great toenail as determined 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 Normal or not clinically significant screening safety labs 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 Diabetes mellitus requiring treatment other than diet and exercise Subjects with chronic moccasin type of T. pedis Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis 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 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 the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks Anti-inflammatories, corticosteroids, topical immunomodulators: 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 dermatophytes: 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>AN2690 Solution, 5.0% | Drug: AN2690 Solution, 5.0%<br>* Once daily application for 180 days<br>|
| Experimental: Group 2<br>AN2690 Solution, 7.5% | Drug: AN2690 Solution, 7.5%<br>* Once daily application for 180 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A calculated endpoint of treatment response at Day 180 comprised of the ISGA, clear nail growth and fungal culture results |  | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological and clinical response of complete responders, partial responders, and non-responder. |  | Days 180 | 

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