Trial Condition(s):

Papulopustular Rosacea

Efficacy of topical azelaic acid 15% gel plus anti-inflammatory dose doxycycline or metronidazole gel 1% plus anti-inflammatory dose doxycycline in moderate papulopustular rosacea

Bayer Identifier:

14366

ClinicalTrials.gov Identifier:

NCT00855595

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

Inclusion Criteria
- Moderate papulopustular rosacea (IGA>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia
Exclusion Criteria
- Sensitivity to any of the treatments used
- Co-existing conditions that would unfavorably influence the course of the disease
 - Pregnant or lactating women
 - Severe rosacea

Trial Summary

Enrollment Goal
207
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kenneth R. Beer, MD, PA

West Palm Beach, United States, 33401

Status
Completed
 
Locations

The Center for Skin Research

Houston, United States, 77056

Status
Completed
 
Locations

James Del Rosso, DO

Henderson, United States, 89052

Status
Completed
 
Locations

Univeristy of Alabama at Birmingham

Birmingham, United States, 35233

Status
Completed
 
Locations

The Grekin Skin Institute

Warren, United States, 48088

Status
Completed
 
Locations

DermResearch, Inc.

Austin, United States, 78759

Status
Completed
 
Locations

Minnesota Clinical Study Center

Fridley, United States, 55432

Status
Completed
 
Locations

(CURTIS) Mass General Women’s Hospitals Harvard Medical School

Boston , United States, 02114-2517

Status
Completed
 
Locations

Progressive Clinical Research

San Antonio, United States, 78229

Status
Completed
 
Locations

Cherry Creek Research, Inc.

Denver, United States, 80209

Status
Completed
 
Locations

Oregon Medical Research Center, PC

Portland, United States, 97223

Status
Completed
 
Locations

Baylor Research Institute

Dallas, United States, 75246

Status
Completed
 
Locations

David M. Pariser, MD

Norfolk, United States, 23507

Status
Completed
 
Locations

DermResearch Center of New York

Stony Brook, United States, 11790

Status
Completed
 
Locations

Dermatology Research Center, Inc

Salt Lake City, United States, 84124

Status
Completed
 
Locations

Jan Fu, MD

Mason, United States, 45040

Status
Completed
 
Locations

Eduardo Tschen, MD

Albuquerque, United States, 87106

Status
Completed
 

Trial Design