Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT01025635
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
* Free of any clinically significant disease which could interfere with the study
* Willingness to follow all study procedures
* Male or female patient at least 18 years of age
Exclusion Criteria:
* Subjects known to be non-responders to azelaic acid
* Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
* Ocular rosacea, phymatous rosacea
* Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
* Facial laser surgery in the 6 weeks prior to the study
* Topical or systemic use of prescription or non-prescription medications to treat rosacea
* Use of any agent other than the investigational drugs to treat rosacea during the study
* Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
* Known hypersensitivity to any ingredients of the investigational product formulation
* Alcohol or drug abuse
* Incapability of giving fully informed consent
* Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
* Participation in another clinical research study within the last 4 weeks before randomization in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01025635
Study Brief:
Protocol Section:
NCT01025635