Cumulative Irritation Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680095
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: AN2690 Other: AN2690 Solution, Vehicle Other: Sodium Lauryl Sulfate, 0.5% Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 21-day Cumulative Irritation Test
Actual Study Start Date : January 31, 2007
Actual Primary Completion Date : February 28, 2007
Actual Study Completion Date : February 28, 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Severe irritation (Grade 3 or 4) observed at any site [ Time Frame: Daily for 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680095

United States, Virginia
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Responsible Party: Pfizer Identifier: NCT00680095     History of Changes
Other Study ID Numbers: AN2690-ONYC-101
C3371011 ( Other Identifier: Alias Study Number )
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by Pfizer:
Fungal Nail

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents