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Melanocortin receptor agonist
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
Phase 2
Recruiting
Research Sponsored by Clinuvel, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to day 168
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a drug called afamelanotide to see if it can help people with vitiligo, a condition that causes skin to lose its color. The drug aims to restore skin color by increasing melanin production.
Eligible Conditions
- Vitiligo
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to day 168
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to day 168
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
Secondary study objectives
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
Change in Quality of life using a vitiligo specific tool (C)
+3 moreSide effects data
From 2009 Phase 3 trial • 100 Patients • NCT0405327045%
Headache
34%
Nausea
17%
Nasopharyngitis
13%
Diarrhoea
13%
Influenza
12%
Fatigue
12%
Dizziness
11%
Back pain
9%
Abdominal pain
8%
Implant site pain
8%
Flushing
8%
Implant site haematoma
8%
Vomiting
7%
Haematoma
7%
Migraine
7%
Abdominal pain upper
7%
Upper respiratory tract infection
7%
Pyrexia
5%
Oedema peripheral
5%
Cough
4%
Oropharyngeal pain
4%
Toothache
1%
Thrombocytopenia
1%
Spinal fracture
1%
Cholelithiasis
1%
Dysmenorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Afamelanotide
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AfamelanotideExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afamelanotide
2014
Completed Phase 3
~520
Find a Location
Who is running the clinical trial?
Clinuvel, Inc.Lead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Vitiligo
200 Patients Enrolled for Vitiligo