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Cumulative Irritation Test

Primary Purpose

Tinea Pedis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AN2718

Sodium Lauryl Sulfate

About this trial

This is an interventional other trial for Tinea Pedis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects must meet all of the following criteria for inclusion in the study.

Healthy volunteers of either sex, at least 18 years of age or older.
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.
Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
Willingness to follow the study procedures and complete the study.
Written informed consent obtained.

Exclusion Criteria:

Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
Chronic asthma will be excluded.
Pregnant or nursing mothers.
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.

Sites / Locations

The Education and Research Foundation, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

AN2718 Cream SF Vehicle

AN2718 Cream SF, 0.3%

AN2718 Cream SF, 1%

AN2718 Gel Vehicle

AN2718 Gel, 1.5%

AN2718 Gel, 2.5%

AN2718 Gel, 5%

AN2718 Gel, 7.5%

Sodium Lauryl Sulfate, 0.5%

Outcomes

Primary Outcome Measures

Irritation Score (5-point scale)

Secondary Outcome Measures

Full Information

NCT ID

NCT00781664

First Posted

October 28, 2008

Last Updated

April 11, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00781664

Brief Title

Cumulative Irritation Test

Official Title

21-Day Cumulative Irritation Test

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinea Pedis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Cream SF Vehicle

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Cream SF, 0.3%

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Cream SF, 1%

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Gel Vehicle

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Gel, 1.5%

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Gel, 2.5%

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Gel, 5%

Arm Title

Arm Type

Experimental

Arm Description

AN2718 Gel, 7.5%

Arm Title

Arm Type

Active Comparator

Arm Description

Sodium Lauryl Sulfate, 0.5%

Intervention Type

Other

Intervention Name(s)

AN2718

Intervention Description

AN2718 Cream SF Vehicle, Daily for up to 21 days

Intervention Type

Drug

Intervention Name(s)

AN2718

Intervention Description

AN2718 Cream SF, 0.3%, Daily for up to 21 days

Intervention Type

Drug

Intervention Name(s)

AN2718

Intervention Description

AN2718 Cream SF, 1%, Daily for up to 21 days

Intervention Type

Other

Intervention Name(s)

AN2718

Intervention Description

AN2718 Gel Vehicle, Daily for up to 21 days

Intervention Type

Drug

Intervention Name(s)

AN2718

Intervention Description

AN2718 Gel, 1.5%, Daily for up to 21 days

Intervention Type

Drug

Intervention Name(s)

AN2718

Intervention Description

AN2718 Gel, 2.5%, Daily for up to 21 days

Intervention Type

Drug

Intervention Name(s)

AN2718

Intervention Description

AN2718 Gel, 5%, Daily for up to 21 days

Intervention Type

Drug

Intervention Name(s)

AN2718

Intervention Description

AN2718 Gel, 7.5%, Daily for up to 21 days

Intervention Type

Other

Intervention Name(s)

Sodium Lauryl Sulfate

Other Intervention Name(s)

SLS

Intervention Description

Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Primary Outcome Measure Information:

Title

Irritation Score (5-point scale)

Time Frame

Daily for 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must meet all of the following criteria for inclusion in the study. Healthy volunteers of either sex, at least 18 years of age or older. 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. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions. Willingness to follow the study procedures and complete the study. Written informed consent obtained. Exclusion Criteria: Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded. Chronic asthma will be excluded. Pregnant or nursing mothers. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

The Education and Research Foundation, Inc.

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

12. IPD Sharing Statement

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Cumulative Irritation Test

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