MedTrace Logo

Topical Safety Study of Topical Diltiazem Hydrochloride

NCT01816529 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-08-21

No results posted yet for this study

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.

Conditions

  • Diltiazem Skin Sensitivity.

Interventions

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.

Sponsors & Collaborators

  • Ventrus Biosciences, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-06-30
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01816529 on ClinicalTrials.gov