Study 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

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

Trial summary

Enrollment Goal

Trial Dates

January 2007 - June 2007

Phase

Phase 4

Could I Receive a placebo

Products

Finacea (Azelaic Acid, BAY39-6251)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Intendis GmbH	Berlin, Germany

Primary Outcome

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

Secondary Outcome

Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy
Time Frame:
Parameters measured during the course of treatment
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

Additional Information

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