The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
44
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States
Irritation Score (5-point scale)
Time frame: Daily for 21 days
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AN2718 Gel Vehicle, Daily for up to 21 days
AN2718 Gel, 1.5%, Daily for up to 21 days
AN2718 Gel, 2.5%, Daily for up to 21 days
AN2718 Gel, 5%, Daily for up to 21 days
AN2718 Gel, 7.5%, Daily for up to 21 days
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days