NCT01816529

Topical Safety Study of Topical Diltiazem Hydrochloride

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Diltiazem Hydrochloride 2% Cream in Healthy Subjects Using a Repeat Insult Patch Test Design

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ventrus Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions.

Detailed description

The primary objective of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream and its vehicle to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions. In addition, the irritation potential of the investigational products will be assessed during the Induction Phase and safety will be assessed by evaluation of any adverse events (AEs) reported during the study.

Conditions

• Diltiazem Skin Sensitivity.

Interventions

Type	Name	Description
DRUG	Diltiazem Hydrochloride 2% Cream	0.2 g applied topically to the infrascapular area of the back.
DRUG	Vehicle Cream	Vehicle Cream, 0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
DRUG	0.1% solution of 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: 2013-06-01
• Completion: 2013-09-01
• First posted: 2013-03-22
• Last updated: 2013-08-21

Locations

1 site across 1 country: United States