Cumulative Irritation Test

Study Overview
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Brief Summary
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The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Detailed Description
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Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.

Official Title
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21-day Cumulative Irritation Test

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: AN2690
* Drug: AN2690
* Drug: AN2690
* Other: AN2690 Solution, Vehicle
* Other: Sodium Lauryl Sulfate, 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, volunteers of either sex, at least 18 years of age or older Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions Subjects were willing to follow the study procedures and complete the study Written informed consent was obtained Exclusion Criteria: Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded Subject was pregnant or nursing Subject had a history of sensitivity to any component of any of the formulations Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AN2690 Solution, 2.5% | Drug: AN2690<br>* AN2690 Solution, 2.5%, Daily for up to 21 days<br>|
| Experimental: B<br>AN2690 Solution, 7.5% | Drug: AN2690<br>* AN2690 Solution, 7.5%, Daily for up to 21 days<br>|
| Experimental: C<br>AN2690 Solution, 5.0% | Drug: AN2690<br>* AN2690 Solution, 5.0%, Daily for up to 21 days<br>|
| Active Comparator: D<br>AN2690 Solution, Vehicle | Other: AN2690 Solution, Vehicle<br>* AN2690 Solution, Vehicle, Daily for up to 21 days<br>|
| Active Comparator: E<br>Sodium Lauryl Sulfate, 0.5% | Other: Sodium Lauryl Sulfate, 0.5%<br>* Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe irritation (Grade 3 or 4) observed at any site |  | Daily for 21 days | 

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