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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT04943159
Eligibility Criteria:
Inclusion Criteria:
* Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;
* Chronic course of acne vulgaris;
* Acne-related lesions both on the face, chest and back;
* Indication for treatment of acne vulgaris;
* Aged 18-30 years (inclusive);
* Fitzpatrick skin types I-III;
* Providing written Informed Consent prior to the performance of any study-specific procedure.
Exclusion Criteria:
* Female subjects;
* Diagnosis of severe acne vulgaris;
* Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant;
* Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;
* Use of oral antibiotics for acne within 4 weeks prior to the first dose;
* Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose;
* Use of systemic retinoids within 6 months prior to the first dose;
* Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;
* Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose;
* Use of tanning booths or lamps within 1 week prior to the first dose;
* Active skin disease that may interfere with evaluation;
* Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;
* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT04943159
Study Brief:
Protocol Section:
NCT04943159