check_circleStudy Completed

Healthy

Bayer Identifier:

15853

ClinicalTrials.gov Identifier:

NCT01430312

EudraCT Number:

Not Available

EU CT Number:

Not Available
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - healthy volunteers
    - male ore 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
40
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

  • irritancy rating scale
    skin reaction as well as superficial layer effects will be scored according to standardized scales
    date_rangeTime Frame:
    21 days
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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