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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: NCT00781664
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : April 16, 2019
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
Tinea Pedis Other: AN2718 Drug: AN2718 Other: Sodium Lauryl Sulfate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: 21-Day Cumulative Irritation Test
Study Start Date : October 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Irritation Score (5-point scale) [ 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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): NCT00781664

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United States, Virginia
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
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Responsible Party: Pfizer Identifier: NCT00781664    
Other Study ID Numbers: AN2718-TP-101
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Tinea Pedis
Skin Diseases, Infectious
Foot Dermatoses
Foot Diseases
Skin Diseases
Skin Manifestations