NCT01821274

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ventrus Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Skin Irritation

Interventions

Type	Name	Description
DRUG	Diltiazem Hydrochloride 2% Cream	0.2 g applied topically to the infrascapular area of the back.
DRUG	Vehicle Cream	0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
DRUG	0.1% solution o sodium lauryl sulfate (SLS)	0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
DRUG	Saline 0.9%	0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2013-03-29
• Last updated: 2013-08-21

Locations

1 site across 1 country: United States