Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea

• Efficacy of Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Evaluation by therapeutic success rate according to Investigators Global Assessment
• Efficacy of Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Evaluation by change in inflammatory lesion count

• Safety and tolerability of topical Azelaic Acid Foam 15% [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  Evaluation of all Adverse Events
• Assess self-reported outcome parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Collection of subject's global assessments on treatment response and tolerability as well as subject's opinion on cosmetic parameters
• Assessment of effect of Azelaic Acid Foam (15%) and vehicle on parameters of quality of life in papulopustular rosacea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Evaluation by using different Quality of Life questionnaires

The purpose of this study is to assess the safety and efficacy of Azelaic Acid Foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

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 and change in inflammatory lesion count from baseline to end of treatment.

• Drug: Azelaic Acid
  twice daily topical application
• Drug: Vehicle Foam
  twice daily topical application

• Experimental: Azelaic Acid Foam 15%
  Intervention: Drug: Azelaic Acid
• Placebo Comparator: Vehicle Foam
  Intervention: Drug: Vehicle Foam

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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, azithromycine, 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