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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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