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21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01430312
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : April 1, 2020
Information provided by (Responsible Party):
LEO Pharma

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.

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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
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT01430312

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United States, North Dakota
Robert I. Cooper, MD
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
LEO Pharma
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Study Director: Bayer Study Director Bayer
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Responsible Party: LEO Pharma Identifier: NCT01430312    
Other Study ID Numbers: 15853
1401841 ( Other Identifier: Company internal )
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: February 2014
Keywords provided by LEO Pharma:
dermal irritative potential
Additional relevant MeSH terms:
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Azelaic acid
Antineoplastic Agents
Dermatologic Agents