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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01038869
Eligibility Criteria:
Inclusion Criteria:
* Male or female, at least 12 years of age
* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
* Fitzpatrick skin type IV to VI
* Acne IGA (Investigator Global Assessment) score of 2 or 3
* Inflammatory lesions of 15-60 (with no more than 2 nodules)
* Non-inflammatory lesions of 20-100
* Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of 3,4 or 5
* Able to understand the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must have the written informed consent of a parent or legal guardian
Exclusion Criteria:
* Female subjects who are pregnant, breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control
* Allergy or sensitivity to any component of the test medication
* Subjects who have not complied with the wash out periods for prohibited medications
* Medical condition that contraindicates participation
* Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH
* Evidence of recent alcohol or drug abuse
* History of poor cooperation, non-compliance or unreliability
* Exposure to an investigational drug study within 30 day of Baseline visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01038869
Study Brief:
Protocol Section:
NCT01038869