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Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea

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.
 
ClinicalTrials.gov Identifier: NCT01257919
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
LEO Pharma

Study Description
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Brief Summary:

Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.

Assessment of safety after repeated skin application.


Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: Azelaic Acid Foam Drug: Azelaic Acid Gel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Azelaic Acid Foam 15%
Dermal application of Azelaic Acid Foam 15%
 Drug: Azelaic Acid Foam
Dermal application of Azelaic Acid Foam
Active Comparator: Azelaic Acid Gel 15%
Dermal application of Azelaic Acid Gel 15%
 Drug: Azelaic Acid Gel
Dermal application of Azelaic Acid Gel


Outcome Measures
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Primary Outcome Measures :
  1. Baseline corrected area under the curve (AUC) [ Time Frame: 12 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of moderate papulopustular rosacea
  • free of any clinically significant disease

Exclusion Criteria:

  • body weight less than 50 or more than 130 kg
  • clinically significant disease which could interfere with the study
Contacts and Locations
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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): NCT01257919


Locations
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United States, Nevada
Novum Pharmaceutical Research Services of Nevada Inc.
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
LEO Pharma
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01257919    
Other Study ID Numbers: 15386
1401843 ( Other Identifier: Company Internal )
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: February 2014
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents