Cumulative Irritation Test - Full Text View

Sponsored by:	Anacor Pharmaceuticals, Inc.
Information provided by:	Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00680095

Purpose

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

Condition	Intervention	Phase
Onychomycosis	Drug: AN2690 Other: AN2690 Solution, Vehicle Other: Sodium Lauryl Sulfate, 0.5%	Phase I

Drug Information available for: AN 2690 Sodium dodecyl sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Safety Study
Official Title:	21-Day Cumulative Irritation Test

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

Primary Outcome Measures:

Severe irritation (Grade 3 or 4) observed at any site [ Time Frame: Daily for 21 days ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	January 2007
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental AN2690 Solution, 2.5%	Drug: AN2690 AN2690 Solution, 2.5%, Daily for up to 21 days
B: Experimental AN2690 Solution, 7.5%	Drug: AN2690 AN2690 Solution, 7.5%, Daily for up to 21 days
C: Experimental AN2690 Solution, 5.0%	Drug: AN2690 AN2690 Solution, 5.0%, Daily for up to 21 days
D: Active Comparator AN2690 Solution, Vehicle	Other: AN2690 Solution, Vehicle AN2690 Solution, Vehicle, Daily for up to 21 days
E: Active Comparator Sodium Lauryl Sulfate, 0.5%	Other: Sodium Lauryl Sulfate, 0.5% Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680095

Locations

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

Sponsors and Collaborators

Anacor Pharmaceuticals, Inc.

Investigators

Study Director:

Karl Beutner, MD, PhD

Anacor Pharmaceuticals, Inc.

More Information

Responsible Party:	Anacor Pharmaceuticals, Inc. ( Karl Beutner, MD, PhD, Chief Medical Officer )
Study ID Numbers:	AN2690-ONYC-101
Study First Received:	May 15, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00680095
Health Authority:	United States: Food and Drug Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:

Onychomycosis
Fungal Nail

Study placed in the following topic categories:

Mycoses
Skin Diseases, Infectious
Onychomycosis

Skin Diseases
Tinea
Dermatomycoses

Additional relevant MeSH terms:

Nail Diseases
Infection

ClinicalTrials.gov processed this record on January 14, 2009