Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Afamelanotide in Patients Suffering With Acne Vulgaris

NCTNCT04943159 (opens ClinicalTrials.gov in a new tab)Other idCUV100
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
3 participants (actual)
Sponsor
Clinuvel Pharmaceuticals Limited · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
24 Aug 2010
Primary completion
8 Mar 2011
Completion
8 Mar 2011
First posted
29 Jun 2021
Last update posted
26 Oct 2021
Conditions
Acne Vulgaris

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 2

    Afamelanotide in Patients Suffering With Acne Vulgaris

    NCT04943159

    24 Aug 2010 to 8 Mar 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AfamelanotideDrug

Arms2

  • Experimental

    Afamelanotide group A

  • Experimental

    Afamelanotide group B

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · From baseline to Day 56.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From baseline to Day 56.

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

GroupValue (Lesions)Spread
Afamelanotide (Pooled Analysis)4630.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Afamelanotide (Pooled Analysis)* Group A are administered afamelanotide implant on Days 0, 21 and 42; * Group B are administered afamelanotide implant on Days 0 and 28.–0 / 31 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 30 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.