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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01257919
First Posted: December 10, 2010
Last Update Posted: February 21, 2014
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.
Information provided by (Responsible Party):
Bayer
  Purpose

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 Intervention Phase
Papulopustular Rosacea Drug: Azelaic Acid Foam Drug: Azelaic Acid Gel Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Enrollment: 21
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Nevada
Novum Pharmaceutical Research Services of Nevada Inc.
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01257919     History of Changes
Other Study ID Numbers: 15386
1401843 ( Other Identifier: Company Internal )
First Submitted: December 9, 2010
First Posted: December 10, 2010
Last Update Posted: February 21, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents