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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT00617903
Eligibility Criteria:
Inclusion Criteria:
* male and female patient at least 18 years of age
* signed informed consent
* Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
* Ability and willingness to accept and comply with treatment and required medical examinations
Exclusion Criteria:
* Known non-responders to azelaic acid
* Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
* Presence of dermatoses that could interfere with the rosacea diagnosis
* Treatment with isotretinoin in the six months prior to randomization
* Treatment of the face with topical retinoids during the two weeks prior to randomization
* Treatment with oral antibiotics during the four weeks prior to randomization
* Treatment with topical antibiotics
* Treatment with systemic corticosteroids during 4 weeks prior to randomization
* Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
* Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
* Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
* Use of a sauna during 2 weeks prior to randomization and during the study
* Facial laser surgery for telangiectasia during 6 weeks prior to randomization
* Planned concurrent use of any treatment other than study medication that affects rosacea
* History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
* Participation in another clinical trial during the last 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00617903
Study Brief:
Protocol Section:
NCT00617903