Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea (NCT01555463) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
United States961 participantsStarted 2012-09
Plain-language summary
The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.
Who can participate
Age range18 Years
SexALL
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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, 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
What they're measuring
1
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
Timeframe: At end of treatment (LOCF), up to 12 weeks
2
Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks