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NCT00781664 Clinical Trial

Cumulative Irritation Test

Tinea Pedis Clinical Trial

Official title:
21-Day Cumulative Irritation Test

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00781664
Other study ID # AN2718-TP-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2008
Est. completion date November 2008

Study information
Verified date April 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 44
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• AN2718
AN2718 Cream SF Vehicle, Daily for up to 21 days
Drug:
• AN2718
AN2718 Cream SF, 0.3%, Daily for up to 21 days
• AN2718
AN2718 Cream SF, 1%, Daily for up to 21 days
Other:
• AN2718
AN2718 Gel Vehicle, Daily for up to 21 days
Drug:
• AN2718
AN2718 Gel, 1.5%, Daily for up to 21 days
• AN2718
AN2718 Gel, 2.5%, Daily for up to 21 days
• AN2718
AN2718 Gel, 5%, Daily for up to 21 days
• AN2718
AN2718 Gel, 7.5%, Daily for up to 21 days
Other:
• Sodium Lauryl Sulfate
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Locations
Country Name City State
United States The Education and Research Foundation, Inc. Lynchburg Virginia

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Irritation Score (5-point scale) Daily for 21 days
See also
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