Skin Irritation Clinical Trial
Official title:
A 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of Diltiazem Hydrochloride 2% Cream in Healthy Subjects, Using a Cumulative Irritant Patch Test Design
The purpose of the study is to determine whether Diltiazem Hydrochloride 2% Cream will cause irritation to skin on the back of healthy volunteers after repeated application over 21-days.
The primary objective of this study will be to determine the potential of Diltiazem
Hydrochloride 2% Cream to cause irritation after repeated topical application to the healthy
skin of humans under controlled conditions.
In addition, safety will be assessed by evaluation of any adverse events (AEs) reported
during the study.
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