An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
This study has been completed.
Information provided by:
First received: February 25, 2010
Last updated: June 8, 2010
Last verified: June 2010
The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.
Drug: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
|Official Title:||An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by LEO Pharma:
Primary Outcome Measures:
- Clinical scoring of the skin reaction. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]Clinical evaluation of the irritation on 8-level scale (from score 0: no evidence of irritation, to score 7: strong reaction speading beyond the application site)
Secondary Outcome Measures:
- Transepidermal waterloss measurements [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Contacts and Locations