Cumulative Irritation Test

April 5, 2019 updated by: Pfizer

21-day Cumulative Irritation Test

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education and Research Foundation, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
AN2690 Solution, 2.5%
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
Experimental: B
AN2690 Solution, 7.5%
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
Experimental: C
AN2690 Solution, 5.0%
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
Active Comparator: D
AN2690 Solution, Vehicle
Other: AN2690 Solution, Vehicle
AN2690 Solution, Vehicle, Daily for up to 21 days
Active Comparator: E
Sodium Lauryl Sulfate, 0.5%
Other: Sodium Lauryl Sulfate, 0.5%
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2007

Primary Completion (Actual)

February 19, 2007

Study Completion (Actual)

February 19, 2007

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN2690-ONYC-101
  • C3371011 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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