Afamelanotide in Patients Suffering With Acne Vulgaris

NCT ID: NCT04943159

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-24
• Study Completion Date: 2011-03-08

Brief Summary

This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afamelanotide group A

Group Type: EXPERIMENTAL

Afamelanotide

Intervention Type: DRUG

Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.

Afamelanotide group B

Group Type: EXPERIMENTAL

Afamelanotide

Intervention Type: DRUG

Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.

Interventions

Afamelanotide

Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Clinuvel Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CUV100

Identifier Type: -

Identifier Source: org_study_id