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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01257919
First received: December 9, 2010
Last updated: February 19, 2014
Last verified: February 2014

December 9, 2010
February 19, 2014
January 2011
March 2011   (final data collection date for primary outcome measure)
Baseline corrected area under the curve (AUC) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01257919 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Papulopustular Rosacea
  • Drug: Azelaic Acid Foam
    Dermal application of Azelaic Acid Foam
  • Drug: Azelaic Acid Gel
    Dermal application of Azelaic Acid Gel
  • Experimental: Azelaic Acid Foam 15%
    Dermal application of Azelaic Acid Foam 15%
    Intervention: Drug: Azelaic Acid Foam
  • Active Comparator: Azelaic Acid Gel 15%
    Dermal application of Azelaic Acid Gel 15%
    Intervention: Drug: Azelaic Acid Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01257919
15386, 1401843
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP