Afamelanotide in Patients Suffering With Acne Vulgaris

NCT04943159 | Completed Phase 2 Results

• 1 other identifier: CUV100
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The Change in Number of Facial Inflammatory Acne-related Lesions.

  From baseline to Day 56.

Study Arms (2)

Afamelanotide group A

EXPERIMENTAL

Drug: Afamelanotide

Afamelanotide group B

EXPERIMENTAL

Drug: Afamelanotide

Interventions

Afamelanotide 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 A; Afamelanotide group B

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

afamelanotide

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Clinical Operations Manager
• Organization: CLINUVEL PHARMACEUTICALS LTD

mail@clinuvel.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: August 24, 2010
• Primary Completion: March 8, 2011
• Study Completion: March 8, 2011
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-09