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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT00752635
Eligibility Criteria:
Inclusion Criteria:
* Female adults who were suffering from moderate acne vulgaris (grade II or III)
* With 6 to 100 comedones (non-inflammatory lesions)
* With 10 to 50 inflammatory lesions (papules or pustules)
* With fewer than 5 nodules
* Agree to condoms or diaphragm, and spermicide or any other medically approved effective barrier method of contraceptive or a nonhormonal IUD
* Agree to take as treatment for acne only for the supplied study drug during the three month treatment phase
* Documented by an informed consent to participate in the trial on the day before entering the study
Exclusion Criteria:
* Patients who, in the investigator's opinion, cannot understand or follow the instructions given in the study
* Who are pregnant or nursing
* Who have clinical depression and are suicidal or require immediate treatment for depression
* Who have a known hypersensitivity to any of the ingredients
* Who are currently having significant adverse experiences from ethinyl estradiol or norgestimate
* Who have any coexisting medical condition or are taking and concomitant to a medication that is likely to interfere with safe administration of TriCilest and/or Diane-35, in the investigator's opinion
* Who take systemic retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively
* Who have any of the following contraindications to oral contraceptives: Current thrombophlebitis or thromboembolic disorders, or past history of deep vein thrombophlebitis or thromboembolic disorder, or cerebral vascular or coronary artery disease or known severe hypertension, or diabetes with vascular involvement, or known or suspected carcinoma of the breast, or known or suspected estrogen-dependent neoplasia, or undiagnosed, abnormal genital bleeding, or benign or malignant liver tumor, or have jaundice or severe liver disease, or neurovascular lesion of the eye or serious visual disturbances, or known allergic reaction or sensitivities to TriCilest or Diane 35
* Who have taken an investigational medication within 30 days prior to enter study (or within a period of five times its half-life or the half-life of its metabolites)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
49 Years
Study:
NCT00752635
Study Brief:
Protocol Section:
NCT00752635