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
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 19, 2007

Detailed Description

Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.

Interventions

  • Drug: AN2690
    • AN2690 Solution, 2.5%, Daily for up to 21 days
  • Drug: AN2690
    • AN2690 Solution, 7.5%, Daily for up to 21 days
  • Drug: AN2690
    • AN2690 Solution, 5.0%, Daily for up to 21 days
  • Other: AN2690 Solution, Vehicle
    • AN2690 Solution, Vehicle, Daily for up to 21 days
  • Other: Sodium Lauryl Sulfate, 0.5%
    • Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Arms, Groups and Cohorts

  • Experimental: A
    • AN2690 Solution, 2.5%
  • Experimental: B
    • AN2690 Solution, 7.5%
  • Experimental: C
    • AN2690 Solution, 5.0%
  • Active Comparator: D
    • AN2690 Solution, Vehicle
  • Active Comparator: E
    • Sodium Lauryl Sulfate, 0.5%

Clinical Trial Outcome Measures

Primary Measures

  • Severe irritation (Grade 3 or 4) observed at any site
    • Time Frame: Daily for 21 days

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy, volunteers of either sex, at least 18 years of age or older – Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active – Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions – Subjects were willing to follow the study procedures and complete the study – Written informed consent was obtained Exclusion Criteria:

  • Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded – Subject was pregnant or nursing – Subject had 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

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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