Status:
COMPLETED
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Lead Sponsor:
LEO Pharma
Collaborating Sponsors:
Bayer
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
Detailed Description
In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potentia...
Eligibility Criteria
Inclusion
- healthy volunteers
- male or female subjects
- aged 18 - 65 years
- ability to understand and fulfill the study requirements
Exclusion
- affected skin in designated test area
- pregnancy or lactation
- not willing to comply with study requirements
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01430533
Start Date
September 1 2011
End Date
December 1 2011
Last Update
April 1 2020
Active Locations (1)
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1
Robert I. Cooper, MD
Fargo, North Dakota, United States, 58104