Overview

Cumulative Irritation Test

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Criteria
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.