21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 6, 2011
Last updated: February 27, 2014
Last verified: February 2014

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

Condition Intervention Phase
Drug: azelaic acid pre-foam formulation
Drug: Vehicle pre-foam formulation
Drug: Water
Drug: Sodium lauryl sulfate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • irritancy rating scale [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    skin reaction as well as superficial layer effects will be scored according to standardized scales

Enrollment: 40
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum
Topical application of verum (azelaic acid pre-foam formulation) on the skin
Drug: azelaic acid pre-foam formulation
Placebo Comparator: Vehicle
Topical application of vehicle formulation (same as verum but without active drug substance) on the skin
Drug: Vehicle pre-foam formulation
Placebo Comparator: Negative control
Topical application of distilled water (negative control) on the skin
Drug: Water
Active Comparator: Positive control
Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin
Drug: Sodium lauryl sulfate

Detailed Description:

This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy volunteers
  • male ore 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430312

United States, North Dakota
Robert I. Cooper, MD
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01430312     History of Changes
Other Study ID Numbers: 15853, 1401841
Study First Received: September 6, 2011
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
dermal irritative potential

Additional relevant MeSH terms:
Azelaic acid
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014