Cumulative Irritation Test

21-Day Cumulative Irritation Test

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

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Other: AN2718; Other: AN2718; Drug: AN2718; Drug: AN2718; Drug: AN2718; Drug: AN2718; Drug: AN2718; Drug: AN2718; Other: Sodium Lauryl Sulfate

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; AN2718 Cream SF Vehicle	Other: AN2718; AN2718 Cream SF Vehicle, Daily for up to 21 days; Other: AN2718; AN2718 Gel 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; Drug: AN2718; AN2718 Cream SF, 1%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 1.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 2.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 7.5%, Daily for up to 21 days
Experimental: C; AN2718 Cream SF, 1%	Drug: AN2718; AN2718 Cream SF, 0.3%, Daily for up to 21 days; Drug: AN2718; AN2718 Cream SF, 1%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 1.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 2.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 7.5%, Daily for up to 21 days
Experimental: D; AN2718 Gel Vehicle	Other: AN2718; AN2718 Cream SF Vehicle, Daily for up to 21 days; Other: AN2718; AN2718 Gel Vehicle, Daily for up to 21 days
Experimental: E; AN2718 Gel, 1.5%	Drug: AN2718; AN2718 Cream SF, 0.3%, Daily for up to 21 days; Drug: AN2718; AN2718 Cream SF, 1%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 1.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 2.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 7.5%, Daily for up to 21 days
Experimental: F; AN2718 Gel, 2.5%	Drug: AN2718; AN2718 Cream SF, 0.3%, Daily for up to 21 days; Drug: AN2718; AN2718 Cream SF, 1%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 1.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 2.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 7.5%, Daily for up to 21 days
Experimental: G; AN2718 Gel, 5%	Drug: AN2718; AN2718 Cream SF, 0.3%, Daily for up to 21 days; Drug: AN2718; AN2718 Cream SF, 1%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 1.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 2.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 7.5%, Daily for up to 21 days
Experimental: H; AN2718 Gel, 7.5%	Drug: AN2718; AN2718 Cream SF, 0.3%, Daily for up to 21 days; Drug: AN2718; AN2718 Cream SF, 1%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 1.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 2.5%, Daily for up to 21 days; Drug: AN2718; AN2718 Gel, 5%, Daily for up to 21 days; 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 Names: SLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Irritation Score (5-point scale)	Daily for 21 days

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 29, 2008

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Tinea; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea Pedis
• Other Study ID Numbers: AN2718-TP-101