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Afamelanotide in Patients Suffering With Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04943159
Recruitment Status : Completed
First Posted : June 29, 2021
Results First Posted : October 26, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Clinuvel Pharmaceuticals Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Afamelanotide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 24, 2010
Actual Primary Completion Date : March 8, 2011
Actual Study Completion Date : March 8, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The Change in Number of Facial Inflammatory Acne-related Lesions. [ Time Frame: From baseline to Day 56. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Clinuvel Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT04943159    
Other Study ID Numbers: CUV100
First Posted: June 29, 2021    Key Record Dates
Results First Posted: October 26, 2021
Last Update Posted: October 26, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
 Sebaceous Gland Diseases
Afamelanotide
Dermatologic Agents