NCT00781664

Cumulative Irritation Test

21-Day Cumulative Irritation Test

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
OTHER	AN2718	AN2718 Cream SF Vehicle, Daily for up to 21 days
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
OTHER	AN2718	AN2718 Gel Vehicle, 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
OTHER	Sodium Lauryl Sulfate	Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-10-29
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States