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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):
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01025635
First received: November 26, 2009
Last updated: March 21, 2012
Last verified: October 2010
History of Changes

November 26, 2009
March 21, 2012
November 2009
October 2010   (final data collection date for primary outcome measure)
Investigators Global Assessment [ Time Frame: Measurement 12 weeks after begin of treatment ] [ Designated as safety issue: No ]
Investigators Global Assessment [ Time Frame: Baseline measurement and measurements at 4, 8, and 12 weeks after begin of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01025635 on ClinicalTrials.gov Archive Site
Inflammatory lesion count (papules and pustules) [ Time Frame: Measurement 12 weeks after begin of treatment ] [ Designated as safety issue: No ]
Inflammatory lesion count (papules and pustules) [ Time Frame: Baseline measurement and measurements at 4, 8, and 12 weeks after begin of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Azelaic Acid Foam 15% in Papulopustular Rosacea
Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate the Safety and Efficacy of Azelaic Acid Foam 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
Not Provided
Interventional
Phase 2
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%
    Applied topically twice daily for 12 weeks
  • Drug: Foam vehicle
    Applied topically twice daily for 12 weeks
  • Active Comparator: Azelaic acid foam 15% topically applied
    This arm will be the active treatment arm.
    Intervention: Drug: Azelaic acid foam 15%
  • Placebo Comparator: Foam without active ingredient
    This arm will be the placebo control.
    Intervention: Drug: Foam vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed written consent
  • Diagnosis of papulopustular rosacea (moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions
  • Free of any clinically significant disease which could interfere with the study
  • Willingness to follow all study procedures

Exclusion Criteria:

  • Subjects known to be non-responders to azelaic acid
  • Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
  • Ocular rosacea, phymatous rosacea
  • Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
  • Facial laser surgery in the 6 weeks prior to the study
  • Topical or systemic use of prescription or non-prescription medications to treat rosacea
  • Use of any agent other than the investigational drugs to treat rosacea during the study
  • Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01025635
1403120
No
Intendis GmbH
Intendis GmbH
Not Provided
Principal Investigator: Boni Elewski, MD University of Alabama at Birmingham
Intendis GmbH
October 2010

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