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

October 28, 2008
November 19, 2008
October 2008
November 2008   (final data collection date for primary outcome measure)
Irritation Score (5-point scale) [ Time Frame: Daily for 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00781664 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cumulative Irritation Test
21-Day Cumulative Irritation Test

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Tinea Pedis
  • Other: AN2718
    AN2718 Cream SF Vehicle, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Cream SF, 0.3%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Cream SF, 1%, Daily for up to 21 days
  • Other: AN2718
    AN2718 Gel Vehicle, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 1.5%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 2.5%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 5%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 7.5%, Daily for up to 21 days
  • Other: Sodium Lauryl Sulfate
    Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
    Other Name: SLS
  • Experimental: A
    AN2718 Cream SF Vehicle
    Intervention: Other: AN2718
  • Experimental: B
    AN2718 Cream SF, 0.3%
    Intervention: Drug: AN2718
  • Experimental: C
    AN2718 Cream SF, 1%
    Intervention: Drug: AN2718
  • Experimental: D
    AN2718 Gel Vehicle
    Intervention: Other: AN2718
  • Experimental: E
    AN2718 Gel, 1.5%
    Intervention: Drug: AN2718
  • Experimental: F
    AN2718 Gel, 2.5%
    Intervention: Drug: AN2718
  • Experimental: G
    AN2718 Gel, 5%
    Intervention: Drug: AN2718
  • Experimental: H
    AN2718 Gel, 7.5%
    Intervention: Drug: AN2718
  • Active Comparator: I
    Sodium Lauryl Sulfate, 0.5%
    Intervention: Other: Sodium Lauryl Sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00781664
AN2718-TP-101
No
Lee Zane, M.D., M.A.S., Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
Not Provided
Study Director: Lee Zane, M.D., M.A.S. Anacor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP