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:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT03402893
Eligibility Criteria:
Inclusion Criteria:
i. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
A female is considered of childbearing potential unless she is:
* postmenopausal for at least 12 months prior to study drug administration
* without a uterus and/or both ovaries; or
* has been surgically sterile for at least 6 months prior to study drug administration
Reliable methods of contraception are:
* intrauterine device in use ≥ 90 days prior to study drug administration;
* barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
* vasectomized partner
\[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.\]
ii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V \& VI Supplement VI) characterized by the following:
* IGA Score for acne vulgaris 3
* IGA Score for PIH 3
iii. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms
Exclusion Criteria:
i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
ii. Allergy/sensitivity to any component of the test treatment
iii. IGA score for acne of 2 (mild) or 4 (severe)
iv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)
v. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
vi. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
vii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
viii. Evidence of recent alcohol or drug abuse
ix. History of poor cooperation, non-compliance with medical treatment, or unreliability
x. Exposure to an investigational study drug within 30 days of the Baseline Visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03402893
Study Brief:
Protocol Section:
NCT03402893