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
  Purpose

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.


Condition Intervention Phase
Papulopustular Rosacea
Drug: Azelaic Acid foam, 15% (BAY39-6251)
Drug: Vehicle Foam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 961
Study Start Date: September 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azelaic Acid Foam 15% Drug: Azelaic Acid foam, 15% (BAY39-6251)
Azelaic Acid
Placebo Comparator: Vehicle Foam Drug: Vehicle Foam
twice daily topical application

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555463

  Show 48 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01555463     History of Changes
Other Study ID Numbers: 16080, 1401846
Study First Received: March 13, 2012
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014