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 @ 12:14 PM
Ignite Modification Date:
2025-12-24 @ 12:14 PM
NCT ID:
NCT00722761
Eligibility Criteria:
Inclusion Criteria:
* Female Subjects 18-45 years of age who have achieved spontaneous menarche.
* A clinical diagnosis of truncal acne vulgaris and the desire for an oral contraceptive for birth control.
* A minimum of 10 but not more than 50 inflammatory lesions on the back and chest combined.
* Maximum of 5 nodules.
* Willing and able to understand and sign informed consent.
* Able to complete study and comply with study procedures.
Exclusion Criteria:
* Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks
* Use of oral antibiotics within 30 days.
* Use of systemic corticosteroids within 4 weeks.
* Use of oral contraceptives within 12 weeks.
* Use of isotretinoin in past six months.
* Use of phototherapy devices for acne such as ClearLight or Zenozapper within 1 week.
* Use of tanning booths or lamps within 1 week prior to baseline.
* BMI \>30
* History of renal insufficiency
* History of hepatic dysfunction
* History of adrenal Insufficiency
* History of vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
* History of hypertension
* Diabetes mellitus with vascular involvement
* Migraine headaches with focal neurological symptoms
* Recent major surgery with prolonged immobilization
* Known or suspected carcinoma of the breast
* Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
* Undiagnosed abnormal genital bleeding
* Cholestatic jaundice of pregnancy or jaundice with prior pill use
* Liver tumor (benign or malignant) or active liver disease
* Smoking \> ½ pack of cigarettes/week
* Regular intake of medications that may increase potassium levels such as NSAIDS, potassium sparing diuretics, potassium supplementation, ACE inhibitors, Angiotensin-II receptor antagonists, heparin and aldosterone antagonists.
* Hypersensitivity to any component of the study drug
* Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
* Subjects who are known to be pregnant or planning a pregnancy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00722761
Study Brief:
Protocol Section:
NCT00722761