Afamelanotide in Patients Suffering With Acne Vulgaris

September 28, 2021 updated by: Clinuvel Pharmaceuticals Limited

A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne Vulgaris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afamelanotide group A
Drug: Afamelanotide
Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.
Experimental: Afamelanotide group B
Drug: Afamelanotide
Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Change in Number of Facial Inflammatory Acne-related Lesions.
Time Frame: From baseline to Day 56.
From baseline to Day 56.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinuvel Pharmaceuticals Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2010

Primary Completion (Actual)

March 8, 2011

Study Completion (Actual)

March 8, 2011

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUV100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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