check_circleStudy Completed

Healthy

Bayer Identifier:

15854

ClinicalTrials.gov Identifier:

NCT01430533

EudraCT Number:

Not Available

EU CT Number:

Not Available
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation

Trial purpose

The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - healthy volunteers
    - male or female subjects
    - aged 18 - 65 years
    - ability to understand and fulfill the study requirements
  • - affected skin in designated test area
    - pregnancy or lactation
    - not willing to comply with study requirements

Trial summary

Enrollment Goal
240
Trial Dates
September 2011 - December 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Robert I. Cooper, MDFargo, 58104, United States

Primary Outcome

  • skin sensitization reaction
    skin reactions will be assessed, using a standardized scoring scale
    date_rangeTime Frame:
    day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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