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 daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will 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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Tinea Pedis

Intervention / Treatment
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* Other: AN2718
* Drug: AN2718
* Drug: AN2718
* Other: AN2718
* Drug: AN2718
* Drug: AN2718
* Drug: AN2718
* Drug: AN2718
* Other: Sodium Lauryl Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria for inclusion in the study. Healthy volunteers of either sex, at least 18 years of age or older. Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions. Willingness to follow the study procedures and complete the study. Written informed consent obtained. Exclusion Criteria: Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded. Chronic asthma will be excluded. Pregnant or nursing mothers. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AN2718 Cream SF Vehicle | Other: AN2718<br>* AN2718 Cream SF Vehicle, Daily for up to 21 days<br>|
| Experimental: B<br>AN2718 Cream SF, 0.3% | Drug: AN2718<br>* AN2718 Cream SF, 0.3%, Daily for up to 21 days<br>|
| Experimental: C<br>AN2718 Cream SF, 1% | Drug: AN2718<br>* AN2718 Cream SF, 1%, Daily for up to 21 days<br>|
| Experimental: D<br>AN2718 Gel Vehicle | Other: AN2718<br>* AN2718 Gel Vehicle, Daily for up to 21 days<br>|
| Experimental: E<br>AN2718 Gel, 1.5% | Drug: AN2718<br>* AN2718 Gel, 1.5%, Daily for up to 21 days<br>|
| Experimental: F<br>AN2718 Gel, 2.5% | Drug: AN2718<br>* AN2718 Gel, 2.5%, Daily for up to 21 days<br>|
| Experimental: G<br>AN2718 Gel, 5% | Drug: AN2718<br>* AN2718 Gel, 5%, Daily for up to 21 days<br>|
| Experimental: H<br>AN2718 Gel, 7.5% | Drug: AN2718<br>* AN2718 Gel, 7.5%, Daily for up to 21 days<br>|
| Active Comparator: I<br>Sodium Lauryl Sulfate, 0.5% | Other: Sodium Lauryl Sulfate<br>* Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days<br>* Other names: SLS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation Score (5-point scale) |  | Daily for 21 days |