Cumulative Irritation Test

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00680095
First received: May 15, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 21-Day Cumulative Irritation Test

Resource links provided by NLM:


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
Experimental: A
AN2690 Solution, 2.5%
Drug: AN2690
AN2690 Solution, 2.5%, Daily for up to 21 days
Experimental: B
AN2690 Solution, 7.5%
Drug: AN2690
AN2690 Solution, 7.5%, Daily for up to 21 days
Experimental: C
AN2690 Solution, 5.0%
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

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
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 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

No publications provided

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

Keywords provided by Anacor Pharmaceuticals, Inc.:
Onychomycosis
Fungal Nail

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014