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Cumulative Irritation Test

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00781664
First received: October 28, 2008
Last updated: November 19, 2008
Last verified: November 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: 21-Day Cumulative Irritation Test

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anacor Pharmaceuticals, Inc.:

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781664

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

No publications provided

Responsible Party: Lee Zane, M.D., M.A.S., Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00781664     History of Changes
Other Study ID Numbers: AN2718-TP-101
Study First Received: October 28, 2008
Last Updated: November 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
 Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013