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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01555463
First received: March 13, 2012
Last updated: January 16, 2014
Last verified: January 2014

March 13, 2012
January 16, 2014
September 2012
January 2014   (final data collection date for primary outcome measure)
  • Efficacy of Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluation by therapeutic success rate according to Investigators Global Assessment
  • Efficacy of Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluation by change in inflammatory lesion count
Same as current
Complete list of historical versions of study NCT01555463 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of topical Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of all Adverse Events
  • Assess self-reported outcome parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Collection of subject's global assessments on treatment response and tolerability as well as subject's opinion on cosmetic parameters
  • Assessment of effect of Azelaic Acid Foam (15%) and vehicle on parameters of quality of life in papulopustular rosacea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluation by using different Quality of Life questionnaires
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea

The purpose of this study is to assess the safety and efficacy of Azelaic Acid Foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

To determine the efficacy of AzA Foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment and change in inflammatory lesion count from baseline to end of treatment.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Papulopustular Rosacea
  • Drug: Azelaic Acid foam, 15% (BAY39-6251)
    Azelaic Acid
  • Drug: Vehicle Foam
    twice daily topical application
  • Experimental: Azelaic Acid Foam 15%
    Intervention: Drug: Azelaic Acid foam, 15% (BAY39-6251)
  • Placebo Comparator: Vehicle Foam
    Intervention: Drug: Vehicle Foam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
961
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of papulopustular rosacea
  • Free of any clinically significant disease, which could interfere with the study
  • Male or female subject aged ≥ 18 years
  • Willingness of subject to follow all study procedures
  • Signed written informed consent before any study-related activities are carried out

Exclusion Criteria:

  • Subjects who are known to be non-responders to azelaic acid
  • Presence of dermatoses that might interfere with rosacea diagnosis
  • Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
  • Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
  • Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
  • Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
  • Known hypersensitivity to any ingredients of the investigational product formulation
  • Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
  • Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01555463
16080, 1401846
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

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