Cumulative Irritation Test

Pfizer

Status and phase: Completed; Phase 1

Conditions: Tinea Pedis

Treatments: Drug: AN2718; Other: Sodium Lauryl Sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00781664

AN2718-TP-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 9 patient groups

A

Experimental group

Description:

AN2718 Cream SF Vehicle

B

Experimental group

Description:

AN2718 Cream SF, 0.3%

Treatment:

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

C

Experimental group

Description:

AN2718 Cream SF, 1%

Treatment:

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

D

Experimental group

Description:

AN2718 Gel Vehicle

E

Experimental group

Description:

AN2718 Gel, 1.5%

Treatment:

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

F

Experimental group

Description:

AN2718 Gel, 2.5%

Treatment:

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

G

Experimental group

Description:

AN2718 Gel, 5%

Treatment:

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

H

Experimental group

Description:

AN2718 Gel, 7.5%

Treatment:

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

Drug: AN2718

I

Active Comparator group

Description:

Sodium Lauryl Sulfate, 0.5%

Treatment:

Other: Sodium Lauryl Sulfate