NCT00680095

Cumulative Irritation Test

21-day Cumulative Irritation Test

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (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 on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	AN2690	AN2690 Solution, 2.5%, Daily for up to 21 days
DRUG	AN2690	AN2690 Solution, 7.5%, Daily for up to 21 days
DRUG	AN2690	AN2690 Solution, 5.0%, Daily for up to 21 days
OTHER	AN2690 Solution, Vehicle	AN2690 Solution, Vehicle, Daily for up to 21 days
OTHER	Sodium Lauryl Sulfate, 0.5%	Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Timeline

• Start date: 2007-01-22
• Primary completion: 2007-02-19
• Completion: 2007-02-19
• First posted: 2008-05-19
• Last updated: 2019-04-09

Locations

1 site across 1 country: United States