Cumulative Irritation Test

NCT ID: NCT00781664

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

AN2718 Cream SF Vehicle

Group Type EXPERIMENTAL

AN2718

Intervention Type OTHER

AN2718 Cream SF Vehicle, Daily for up to 21 days

B

AN2718 Cream SF, 0.3%

Group Type EXPERIMENTAL

AN2718

Intervention Type DRUG

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

C

AN2718 Cream SF, 1%

Group Type EXPERIMENTAL

AN2718

Intervention Type DRUG

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

D

AN2718 Gel Vehicle

Group Type EXPERIMENTAL

AN2718

Intervention Type OTHER

AN2718 Gel Vehicle, Daily for up to 21 days

E

AN2718 Gel, 1.5%

Group Type EXPERIMENTAL

AN2718

Intervention Type DRUG

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

F

AN2718 Gel, 2.5%

Group Type EXPERIMENTAL

AN2718

Intervention Type DRUG

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

G

AN2718 Gel, 5%

Group Type EXPERIMENTAL

AN2718

Intervention Type DRUG

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

H

AN2718 Gel, 7.5%

Group Type EXPERIMENTAL

AN2718

Intervention Type DRUG

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

I

Sodium Lauryl Sulfate, 0.5%

Group Type ACTIVE_COMPARATOR

Sodium Lauryl Sulfate

Intervention Type OTHER

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

Interventions

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AN2718

AN2718 Cream SF Vehicle, Daily for up to 21 days

Intervention Type OTHER

AN2718

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

Intervention Type DRUG

AN2718

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

Intervention Type DRUG

AN2718

AN2718 Gel Vehicle, Daily for up to 21 days

Intervention Type OTHER

AN2718

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

Intervention Type DRUG

AN2718

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

Intervention Type DRUG

AN2718

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

Intervention Type DRUG

AN2718

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

Intervention Type DRUG

Sodium Lauryl Sulfate

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

Intervention Type OTHER

Other Intervention Names

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SLS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The Education and Research Foundation, Inc.

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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AN2718-TP-101

Identifier Type: -

Identifier Source: org_study_id

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