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21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

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ClinicalTrials.gov Identifier: NCT01430312
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.

Condition or disease Intervention/treatment Phase
Healthy Drug: azelaic acid pre-foam formulation Drug: Vehicle pre-foam formulation Drug: Water Drug: Sodium lauryl sulfate Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. irritancy rating scale [ Time Frame: 21 days ]
    skin reaction as well as superficial layer effects will be scored according to standardized scales


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01430312     History of Changes
Other Study ID Numbers: 15853
1401841 ( Other Identifier: Company internal )
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Bayer:
dermal irritative potential

Additional relevant MeSH terms:
Azelaic acid
Antineoplastic Agents
Dermatologic Agents