Trial Condition(s):
Healthy
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
Bayer Identifier:
15853
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.
Inclusion Criteria
- healthy volunteers - male ore female subjects - aged 18 - 65 years - ability to understand and fulfill the study requirements
Exclusion Criteria
- affected skin in designated test area - pregnancy or lactation - not willing to comply with study requirements
Trial Summary
Enrollment Goal
40
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Robert I. Cooper, MD Fargo, United States, 58104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- irritancy rating scaleskin reaction as well as superficial layer effects will be scored according to standardized scalesTimeframe: 21 days
Additional Information
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