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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03076320
Eligibility Criteria:
Inclusion Criteria:
* Subjects of both genders male or female of any race, 12 to 25 years or age.
* Subjects with a clinical diagnosis of acne vulgaris with facial and back involvement.
* Subjects with a minimum of 20 but not more tan 150 inflammatory lesions on the face (including the nose)
* Subjects with a minimum of 30 but no more 200 non-inflammatory lesions on the face (including the nose)
* Subjects with minimum of 20 but no more than 250 inflammatory lesions on the superior back area.
* Investigator's Global Assessment (IGA) score of 3 or 4, corresponding to moderate and severe acne. Subjects with no more than two active nodules at baseline.
* Subjects that agree to fill a clinical history, access to physical exploration and biochemical analysis samples, biopsy of the back and photo-documentation of affected areas on the face and back.
* Consent to participate, verified by signing an approved written Informed Consent Form, or for subjects under age 18, an assent form in conjunction with a signed Informed Consent Form from a parent/guardian.
* Patients willing to sign a compliance letter to apply treatment as indicated by the principal investigator.
* Willingness and capacity of protocol compliance (for subjects under 18 years of age, parent/guardian must be wiling and able to comply with study requirements).
* Subjects willing to share personal information and data as verified by signing a written authorization, as applicable
Exclusion Criteria:
* Acne conglobata, acne fulminans, secondary acne.
* Subjects with another chronic inflammatory disease of the skin.
* Subjects with severe acne requiring isotretinoin therapy or other dermatological conditions, which might, in the opinion of the Investigator, interfere with the study evaluation or pose a risk to patient safety during the study.
* Pregnancy, nursing or planning a pregnancy.
* Men with facial hair that would interfere with the assessments.
* Subjects with background history of keloid scarring.
* Known sensitivities to the study preparations.
* Participation in another investigational drug or device research study within 30 day of enrollment.
* Specified washout period to baselines for systemic or topical medications.
* Subjects refusing to the biopsy of the back and photographic procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
25 Years
Study:
NCT03076320
Study Brief:
Protocol Section:
NCT03076320