Status:
COMPLETED
Cumulative Irritation Test
Lead Sponsor:
Pfizer
Conditions:
Tinea Pedis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 conse...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00781664
Start Date
October 1 2008
End Date
November 1 2008
Last Update
April 16 2019
Active Locations (1)
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1
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501