Status:
COMPLETED
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Lead Sponsor:
LEO Pharma
Collaborating Sponsors:
Bayer
Conditions:
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00617903
Start Date
January 1 2008
End Date
June 1 2008
Last Update
April 7 2020
Active Locations (7)
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1
Denver, Colorado, United States, 80209
2
Olathe, Kansas, United States, 66062
3
Henderson, Nevada, United States, 89052
4
Albuquerque, New Mexico, United States, 87106