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Cumulative Irritation Test

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00781664
Collaborator
(none)
44
Enrollment
1
Location
9
Arms
1
Duration (Months)
43.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
21-Day Cumulative Irritation Test
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

AN2718 Cream SF Vehicle

Other: AN2718
AN2718 Cream SF Vehicle, Daily for up to 21 days
Experimental: B

AN2718 Cream SF, 0.3%

Drug: AN2718
AN2718 Cream SF, 0.3%, Daily for up to 21 days
Experimental: C

AN2718 Cream SF, 1%

Drug: AN2718
AN2718 Cream SF, 1%, Daily for up to 21 days
Experimental: D

AN2718 Gel Vehicle

Other: AN2718
AN2718 Gel Vehicle, Daily for up to 21 days
Experimental: E

AN2718 Gel, 1.5%

Drug: AN2718
AN2718 Gel, 1.5%, Daily for up to 21 days
Experimental: F

AN2718 Gel, 2.5%

Drug: AN2718
AN2718 Gel, 2.5%, Daily for up to 21 days
Experimental: G

AN2718 Gel, 5%

Drug: AN2718
AN2718 Gel, 5%, Daily for up to 21 days
Experimental: H

AN2718 Gel, 7.5%

Drug: AN2718
AN2718 Gel, 7.5%, Daily for up to 21 days
Active Comparator: I

Sodium Lauryl Sulfate, 0.5%

Other: Sodium Lauryl Sulfate
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Other Names:
  • SLS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Irritation Score (5-point scale) [Daily for 21 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Education and Research Foundation, Inc. Lynchburg Virginia United States 24501

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00781664
    Other Study ID Numbers:
    • AN2718-TP-101
    First Posted:
    Oct 29, 2008
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Additional relevant MeSH terms:
    Tinea Pedis

    Study Results

    No Results Posted as of Apr 16, 2019