Trial Condition(s):
Healthy
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Study Completed
Trial Purpose
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
Inclusion Criteria
- healthy volunteers - male or 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
240
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 to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- skin sensitization reactionskin reactions will be assessed, using a standardized scoring scaleTimeframe: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)
Additional Information
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