Cumulative Irritation Test
- Conditions
- Tinea Pedis
- Interventions
- Drug: AN2718Other: Sodium Lauryl Sulfate
- Registration Number
- NCT00781664
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B AN2718 AN2718 Cream SF, 0.3% E AN2718 AN2718 Gel, 1.5% H AN2718 AN2718 Gel, 7.5% I Sodium Lauryl Sulfate Sodium Lauryl Sulfate, 0.5% C AN2718 AN2718 Cream SF, 1% G AN2718 AN2718 Gel, 5% A AN2718 AN2718 Cream SF Vehicle D AN2718 AN2718 Gel Vehicle F AN2718 AN2718 Gel, 2.5%
- Primary Outcome Measures
Name Time Method Irritation Score (5-point scale) Daily for 21 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Education and Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States