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Keep this study
Lead
LEO Pharma
With
Bayer
To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment.
Evaluation of all adverse events will be covered in Adverse Events section.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of papulopustular rosacea
Free of any clinically significant disease, which could interfere with the study
Male or female subject aged ≥ 18 years
Willingness of subject to follow all study procedures
Signed written informed consent before any study-related activities are carried out
You may not be if
Subjects who are known to be non-responders to azelaic acid
Presence of dermatoses that might interfere with rosacea diagnosis
Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
Known hypersensitivity to any ingredients of the investigational product formulation
Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
Clareo Health | Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
