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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417937
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : February 21, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: azelaic acid 15% gel Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417937

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

Additional Information:
Responsible Party: Bayer Identifier: NCT00417937     History of Changes
Other Study ID Numbers: 14428
1401460 ( Other Identifier: Company internal )
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents