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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: December 9, 2010
Last updated: February 19, 2014
Last verified: February 2014

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


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

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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Please refer to this study by its identifier: NCT01257919

United States, Nevada
Novum Pharmaceutical Research Services of Nevada Inc.
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01257919     History of Changes
Other Study ID Numbers: 15386
1401843 ( Other Identifier: Company Internal )
Study First Received: December 9, 2010
Last Updated: February 19, 2014

Additional relevant MeSH terms:
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents processed this record on September 21, 2017