Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

Completed · Phase 2

Conditions studied: Papulopustular Rosacea

In brief

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.

Key facts

Study ID

NCT00617903

Run by

LEO Pharma

People needed

83

Starts

2008-01-01

Expected to finish

2008-06-01

Last updated by the study team

2020-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Denver, Colorado, United States
• Study site — Olathe, Kansas, United States
• Study site — Henderson, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Mason, Ohio, United States
• Study site — Austin, Texas, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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