Tinea Pedis
Conditions
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.
Interventions
OTHERAN2718
AN2718 Cream SF Vehicle, Daily for up to 21 days
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following criteria for inclusion in the study. 1. Healthy volunteers of either sex, at least 18 years of age or older. 2. 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. 3. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions. 4. Willingness to follow the study procedures and complete the study. 5. Written informed consent obtained.
Exclusion criteria
1. Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded. 2. Chronic asthma will be excluded. 3. Pregnant or nursing mothers. 4. A history of sensitivity to any component of any of the formulations. 5. Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritation Score (5-point scale) | Daily for 21 days |
Countries
United States
Outcome results
None listed