check_circleStudy Completed

Papulopustular Rosacea

Bayer Identifier:

14428

ClinicalTrials.gov Identifier:

NCT00417937

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

Trial 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.

Key Participants Requirements

Sex

Both

Age

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

Trial summary

Enrollment Goal
98
Trial Dates
January 2007 - June 2007
Phase
Phase 4
Could I Receive a placebo
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Intendis GmbHBerlin, Germany

Primary Outcome

  • Investigator's global assessment scored on a seven point scale
    date_rangeTime Frame:
    Measurements made during the course of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy
    date_rangeTime Frame:
    Parameters measured during the course of treatment
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.