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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
  Purpose

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.


Condition Intervention Phase
Papulopustular Rosacea
 Drug: Azelaic acid foam 15%
Drug: Foam vehicle
 Phase 2

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: 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

Resource links provided by NLM:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:
  • Investigators Global Assessment [ Time Frame: Measurement 12 weeks after begin of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory lesion count (papules and pustules) [ Time Frame: Measurement 12 weeks after begin of treatment ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azelaic acid foam 15% topically applied
This arm will be the active treatment arm.
 Drug: Azelaic acid foam 15%
Applied topically twice daily for 12 weeks
Placebo Comparator: Foam without active ingredient
This arm will be the placebo control.
 Drug: Foam vehicle
Applied topically twice daily for 12 weeks

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025635

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States
Sponsors and Collaborators
Intendis GmbH
Investigators
Principal Investigator: Boni Elewski, MD University of Alabama at Birmingham
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or production occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Intendis GmbH
ClinicalTrials.gov Identifier: NCT01025635     History of Changes
Other Study ID Numbers: 1403120
Study First Received: November 26, 2009
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 13, 2013