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Melanocortin receptor agonist

Afamelanotide for Vitiligo

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

Summary

This trialwill test a drug to help restore skin color in people with vitiligo on the face and body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to day 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to day 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
Secondary outcome measures
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 more

Side effects data

From 2009 Phase 3 trial • 100 Patients • NCT04053270
45%
Headache
34%
Nausea
17%
Nasopharyngitis
13%
Diarrhoea
13%
Influenza
12%
Dizziness
12%
Fatigue
11%
Back pain
9%
Abdominal pain
8%
Implant site haematoma
8%
Vomiting
8%
Implant site pain
8%
Flushing
7%
Abdominal pain upper
7%
Upper respiratory tract infection
7%
Pyrexia
7%
Migraine
7%
Haematoma
5%
Oedema peripheral
5%
Cough
4%
Toothache
4%
Oropharyngeal pain
1%
Spinal fracture
1%
Thrombocytopenia
1%
Cholelithiasis
1%
Dysmenorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Afamelanotide
Placebo

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
~2 spots leftby Jul 2025