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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

Study 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged eighty or above currently being enrolled for this research endeavor?

"Those that are over 18 years old and below 75 can enrol in this medical trial."

Answered by AI

Who is best suited for inclusion in this research experiment?

"For this clinical trial, six volunteers between 18 and 75 with vitiligo need to be recruited. Additionally, they must fulfill several other criteria: gender (male/female), T-VASI score of 0.3-50, F-VASI score over 0.25, no substantial progression in 3 months prior the first implantation session and Fitzpatrick types IV-VI; NB-UVB light therapy twice or three times a week is also required for priming purposes before commencing treatment."

Answered by AI

Are there still spots available to join this research initiative?

"According to clinicaltrials.gov, this research initiative is actively looking for participants. It was originally published on October 11th 2022 and updated lastly on the 20th of that month."

Answered by AI

To what degree can Afamelanotide be deemed a risk to patients?

"The safety profile of Afamelanotide was given a rating of 2, due to the Phase 2 nature of this trial. Evidence suggests that there is some data supporting its security, but none demonstrating efficacy."

Answered by AI

How many participants have been enrolled in this trial thus far?

"Affirmative. Clinicaltrials.gov's portal shows that this medical experiment, initially posted on October 11th 2022, is actively seeking participants to participate in their research. 6 patients are needed from one single clinical site."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Michigan
Ontario
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
What site did they apply to?
CLINUVEL Investigational site

Why did patients apply to this trial?

I have been treated for vitiligo for more than 25 years. It is still progressing.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
2022. "A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05210582.
All > Vitiligo
~2 spots leftby May 2025
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