Acne vulgaris MedDRA version: 12.1 Level: LLT Classification code 10000519 Term: Acne vulgaris
Conditions
Sponsors
Clinuvel Pharmaceuticals Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: To be eligible to enter the study, patients must meet the following inclusion criteria: - Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an 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; - Agreeing to keep identical their shaving habits on the face during the entire study course; and - Providing written Informed Consent prior to the performance of any study-specific procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible to enter the study, patients must not meet any of the following exclusion criteria: - Female subjects; - Diagnosis of severe acne vulgaris, defined as an IGA score of 4; - Indication for treatment of acne vulgaris with isotretinoin therapy; - Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anaesthetic 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 inhaled, intra-articular or intra-lesional (other than for facial, chest and back acne lesions) steroids is acceptable; - 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(TM) or Zenozapper within 1 week prior to the first dose; - Use of tanning booths or lamps within 1 week prior to the first dose; - Use of the following types of products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild cleansers or moisturizers that contain retinol, salicylic acid or a- or ß-hydroxy acids for less than 2 weeks prior to the first dose; - Have had the following types of procedures: chemical or laser peel, microdermabrasion or artificial UV therapy, performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks prior to the first dose; - Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi; - Any malignant or premalignant skin lesions; - Active skin disease that may interfere with evaluation; - Diagnosed with HIV/AIDS or hepatitis; - Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator; - History of systemic or psychiatric disease judged to be clinically significant by the Investigator; - Acute history of drug or alcohol abuse in the last 12 months; - Smoking; - Patients who are expected to suffer from specific forms of severe stress such as university or other examinations, recent divorce, death and life-threatening illness of a family member or partner; - Sexually active men with partners of childbearing potential not using barrier contraception during the trial and for a period of three months thereafter; - Have been shaving their back and/or chest 4 weeks prior to the screening visit; - Beard, moustache, sideburns (temporal zygomatic hair) or any other facial hair 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; - History of significant post-inflammatory hyperpigmentation at the sites of acne lesions; - History of keloid formation for subjects undergoing biopsies; - Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit; - Unwilling or failing to adhere to washout periods for specified treatments or procedures; and - Patients assessed as not suita
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: - To determine the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris.;Secondary Objective: Secondary objectives: - To determine the effect of afamelanotide on the facial total and non-inflammatory acne-related lesions in patients with mild to moderate acne vulgaris; - To determine the effect of afamelanotide on the overall severity of acne in patients with mild to moderate acne vulgaris; - To determine the effect of afamelanotide on inflammatory biomarkers (cytokines) in patients with mild to moderate acne vulgaris; - To determine whether afamelanotide can improve the quality of life of patients with mild to moderate acne vulgaris; - To compare the effect of two dosage regimens of afamelanotide in patients with mild to moderate acne vulgaris; - To determine the effect of afamelanotide on skin melanin density in patients with mild to moderate acne vulgaris; and - To determine the safety and tolerability of afamelanotide in patients with mild to moderate acne vulgaris. ;Primary end point(s): The primary efficacy endpoint of this study is: The percent change in the facial inflammatory acne-related lesions count from baseline to Day 56. This will be done on polled data from Groups A and B. H0: there will be no percent change in the facial inflammatory acne-related lesions count following afamelanotide treatment. | — |
Countries
Germany
Outcome results
None listed