Trial Condition(s):
Healthy
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Bayer Identifier:
15854
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| 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
Copyright © Bayer
Powered by
