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

NCT01821274 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-21

No results posted yet for this study

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.

Conditions

  • Skin Irritation

Interventions

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.

Sponsors & Collaborators

  • Ventrus Biosciences, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-07-31
Completion
2013-09-30

Countries

  • United States

Study Locations

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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 NCT01821274 on ClinicalTrials.gov