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Cumulative Irritation Test

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: October 28, 2008
Last updated: November 19, 2008
Last verified: November 2008
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Condition Intervention Phase
Tinea Pedis Other: AN2718 Drug: AN2718 Other: Sodium Lauryl Sulfate Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: 21-Day Cumulative Irritation Test

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Irritation Score (5-point scale) [ Time Frame: Daily for 21 days ]

Enrollment: 44
Study Start Date: October 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SLS

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00781664

United States, Virginia
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Study Director: Lee Zane, M.D., M.A.S. Pfizer
  More Information

Responsible Party: Lee Zane, M.D., M.A.S., Anacor Pharmaceuticals, Inc. Identifier: NCT00781664     History of Changes
Other Study ID Numbers: AN2718-TP-101
Study First Received: October 28, 2008
Last Updated: November 19, 2008

Additional relevant MeSH terms:
Tinea Pedis
Skin Diseases, Infectious
Foot Dermatoses
Foot Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms processed this record on August 18, 2017