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A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

This study has been completed.
Sponsor:
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00417937
First received: January 2, 2007
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  Purpose

To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.


Condition Intervention Phase
Papulopustular Rosacea
 Drug: azelaic acid 15% gel
 Phase 4

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 Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice 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:
  • Investigator's global assessment scored on a seven point scale [ Time Frame: Measurements made during the course of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy [ Time Frame: Parameters measured during the course of treatment ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: January 2007
Study Completion Date: June 2007
Arms Assigned Interventions
Active Comparator: 1
Azelaic acid 15 % gel once daily
 Drug: azelaic acid 15% gel
15% gel, topically applied once daily for six weeks
Active Comparator: 2
Azelaic acid 15 gel twice daily
 Drug: azelaic acid 15% gel
15% gel, topically applied twice daily for six weeks

Detailed Description:

To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

  Eligibility

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

Inclusion Criteria:

  • Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

Exclusion Criteria:

  • Mild or severe rosacea
  • Rosacea with marked ocular manifestations
  • Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
  • Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
  • History of hypersensitivity to propylene glycol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417937

Locations
Germany
Intendis GmbH
Berlin, Germany
Sponsors and Collaborators
Intendis GmbH
Investigators
Study Director: Intendis GmbH Intendis GmbH
  More Information

Additional Information:
(Click here and search for drug information provided by the FDA)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Klaus Graupe/Senior Medical Advisor, Intendis GmbH
ClinicalTrials.gov Identifier: NCT00417937     History of Changes
Other Study ID Numbers: 1401460
Study First Received: January 2, 2007
Last Updated: December 3, 2007
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 May 23, 2013