Afamelanotide in Patients Suffering With Acne Vulgaris

This is an interventional treatment trial for Acne Vulgaris Read More

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.