21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01430312
First received: September 6, 2011
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Healthy
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430312

Locations
United States, North Dakota
Robert I. Cooper, MD
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Bayer
Investigators
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 July 29, 2014