Trial Condition(s):

Papulopustular Rosacea

Exploration of safety and efficacy of AzA 15% foam twice a day in rosacea

Bayer Identifier:

1402140

ClinicalTrials.gov Identifier:

NCT00617903

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Inclusion Criteria
- male and female patient at least 18 years of age
 - signed informed consent
 - Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia 
 - Ability and willingness to accept and comply with treatment and required medical examinations
Exclusion Criteria
- Known non-responders to azelaic acid 
 - Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea 
 - Presence of dermatoses that could interfere with the rosacea diagnosis 
 - Treatment with isotretinoin in the six months prior to randomization 
 - Treatment of the face with topical retinoids during the two weeks prior to randomization 
 - Treatment with oral antibiotics during the four weeks prior to randomization
 - Treatment with topical antibiotics
 - Treatment with systemic corticosteroids during 4 weeks prior to randomization
 - Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
 - Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
 - Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
 - Use of a sauna during 2 weeks prior to randomization and during the study
 - Facial laser surgery for telangiectasia during 6 weeks prior to randomization
 - Planned concurrent use of any treatment other than study medication that affects rosacea
 - History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
 - Participation in another clinical trial during the last 4 weeks

Trial Summary

Enrollment Goal
83
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Henderson, United States, 89052

Status
Completed
 
Locations

Investigative Site

Mason, United States, 45040

Status
Completed
 
Locations

Cherry Creek Research, Inc

Denver, United States, 80209

Status
Completed
 
Locations

VCR Office

Norfolk, United States, 23507

Status
Completed
 
Locations

Compliant Clinical Research

Olathe, United States, 66062

Status
Completed
 
Locations

Academic Dermatology

Albuquerque, United States, 87106

Status
Completed
 
Locations

Derm Research, Inc

Austin, United States, 78759

Status
Completed
 

Trial Design