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A 21-Day Topical Safety Study of Diltiazem Hydrochloride Using a Cumulative Irritant Patch Test Design

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01821274
Study type Interventional
Source Ventrus Biosciences, Inc
Contact
Status Unknown status
Phase Phase 1
Start date March 2013
Completion date September 2013
View Details
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