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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.
Information provided by (Responsible Party):
Bayer Identifier:
First received: January 2, 2007
Last updated: February 20, 2014
Last verified: February 2014
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Investigator's global assessment scored on a seven point scale [ Time Frame: Measurements made during the course of treatment ]

Secondary Outcome Measures:
  • Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy [ Time Frame: Parameters measured during the course of treatment ]

Enrollment: 98
Study Start Date: January 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00417937

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

Additional Information:
Responsible Party: Bayer Identifier: NCT00417937     History of Changes
Other Study ID Numbers: 14428
1401460 ( Other Identifier: Company internal )
Study First Received: January 2, 2007
Last Updated: February 20, 2014

Additional relevant MeSH terms:
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents processed this record on July 21, 2017