Cumulative Irritation Test

Overview

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

Full Title of Study: “21-Day Cumulative Irritation Test”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: November 2008

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

  • 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
  • Drug: 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
  • Drug: AN2718
    • AN2718 Gel, 2.5%, Daily for up to 21 days
  • Drug: AN2718
    • AN2718 Gel, 5%, Daily for up to 21 days
  • Drug: 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

Arms, Groups and Cohorts

  • Experimental: A
    • AN2718 Cream SF Vehicle
  • Experimental: B
    • AN2718 Cream SF, 0.3%
  • Experimental: C
    • AN2718 Cream SF, 1%
  • Experimental: D
    • AN2718 Gel Vehicle
  • Experimental: E
    • AN2718 Gel, 1.5%
  • Experimental: F
    • AN2718 Gel, 2.5%
  • Experimental: G
    • AN2718 Gel, 5%
  • Experimental: H
    • AN2718 Gel, 7.5%
  • Active Comparator: I
    • Sodium Lauryl Sulfate, 0.5%

Clinical Trial Outcome Measures

Primary Measures

  • Irritation Score (5-point scale)
    • Time Frame: Daily for 21 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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