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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
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.
Details
| Lead sponsor | Ventrus Biosciences, Inc |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 30 |
| Start date | 2013-03 |
| Completion | 2013-09 |
Conditions
- Skin Irritation
Interventions
- Diltiazem Hydrochloride 2% Cream
- Vehicle Cream
- 0.1% solution o sodium lauryl sulfate (SLS)
- Saline 0.9%
Primary outcomes
- Mean cumulative irritation score of Diltiazem Hydrochloride 2% Cream in healthy skin of humans. — 21 days
The primary variable of interest is the mean cumulative irritation score. The mean cumulative irritation score for each subject, product and site will be calculated as the sum of the irritation scores divided by the number of readings. The total cumulative irritation score for each subject and product will also be calculated as the sum of irritation scores on each of 21 evaluation days. A normalized total score for each patch will be calculated by summing the total irritation scores for all subjects, dividing by the number of readings and multiplying by 210. These parameters will be tested pairwise for product differences using Fisher's protected least significant differences in the context of the analysis of variance (ANOVA), including effects of subject and product (ie, randomized complete blocks). All pairwise differences will be tested. No adjustment for multiple comparisons will be made.
Countries
United States