Not recruiting

Study on Afamelanotide and NB-UVB Light for Vitiligo Treatment in Patients with Vitiligo

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying vitiligo, a condition where the skin loses its pigment, resulting in white patches. The study will explore the effectiveness and safety of a treatment involving a medication called SCENESSE (which contains the active substance afamelanotide) combined with a type of light therapy known as Narrow-Band Ultraviolet B (NB-UVB) light. The trial will compare this combination treatment to the use of NB-UVB light therapy alone.

The purpose of the study is to evaluate how well the combination of SCENESSE and NB-UVB light therapy works in helping the skin regain its color compared to using NB-UVB light therapy by itself. Participants in the study will receive either the combination treatment or just the NB-UVB light therapy. The study will monitor the progress of repigmentation, which is the return of color to the skin, and will also look at how quickly this repigmentation begins, especially on the face.

The trial is designed to provide insights into whether adding SCENESSE to the NB-UVB light therapy can improve outcomes for people with vitiligo. The study will take place over a period of time, and participants will be observed to see how their skin responds to the treatments. The findings from this study could help in understanding better ways to manage and treat vitiligo in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants must have a confirmed diagnosis of generalized vitiligo on the face and body. The condition should be stable or active for at least three months.
Participants should have Fitzpatrick skin types IV-VI and must provide written informed consent before any study-specific procedures are performed.
Step 2
Treatment initiation
The study involves two treatment groups. One group receives the SCENESSE 16 mg implant administered subcutaneously, along with narrow-band ultraviolet B (NB-UVB) light therapy. The other group receives only NB-UVB light therapy.
The SCENESSE implant is a small device placed under the skin to release medication over time.
Step 3
Treatment administration
Participants receiving the SCENESSE implant will have it administered at regular intervals as determined by the study protocol.
NB-UVB light therapy sessions are conducted according to a schedule set by the study team, focusing on areas affected by vitiligo.
Step 4
Monitoring and evaluation
Throughout the study, participants are monitored for any changes in their condition and any side effects from the treatments.
The primary goal is to assess the percentage of participants achieving repigmentation with the combination of SCENESSE and NB-UVB compared to NB-UVB alone.
Step 5
Study completion
The study is expected to conclude by October 31, 2025. Participants will undergo final assessments to evaluate the outcomes of the treatments.
Secondary outcomes include the time to onset of repigmentation, particularly on the face.

Who can join the trial?

5 criteria

Male and female participants with a confirmed diagnosis of generalized vitiligo on the face and body. Vitiligo is a condition where the skin loses its color in patches.
Participants must have either stable or active vitiligo that has been diagnosed for at least three months. "Stable" means the condition hasn't changed much, while "active" means it might be spreading or changing.
Participants should have Fitzpatrick skin types IV-VI. This refers to a scale that classifies skin types based on their response to sunlight. Types IV-VI generally include darker skin tones.
Participants must be willing and able to follow the study's rules and procedures, as judged by the study doctor.
Participants need to provide written Informed Consent before any study-specific procedures are done. This means they agree to participate after being informed about the study details.

Who cannot join the trial?

7 criteria

Patients who have any other skin condition that might interfere with the study.
Patients who are currently using any medication that could affect the skin or immune system.
Patients who have a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a history of skin cancer.
Patients who have any medical condition that the study doctor believes could make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Universitaire De La Reunion
Verified
St Denis, France
Centre Hospitalier Universitaire De Nice
Verified
Nice, France
Ospedale Israelitico
Verified
Rome, Italy

Trial locations

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Investigated drugs

SCENESSE
is a medication used in this trial to help with the repigmentation of skin in people with vitiligo. It is being tested to see if it can improve the effects of light therapy in restoring skin color.
Narrow-Band Ultraviolet B (NB-UVB) Light
is a type of light therapy used to treat vitiligo. It involves exposing the skin to a specific wavelength of ultraviolet light to help restore skin color. In this trial, it is used both alone and in combination with SCENESSE to evaluate its effectiveness.

Afamelanotide

What is already known about the treatment

Scenesse – Scenesse is administered as an implant placed under the skin. It is currently being studied in clinical trials for its effectiveness in treating vitiligo, a condition that causes loss of skin color in patches. The main therapeutic indication for Scenesse is to aid in the repigmentation of skin affected by vitiligo. At the molecular level, Scenesse works by activating the melanocortin 1 receptor, which stimulates the production of melanin, the pigment responsible for skin color. It is classified pharmacologically as a melanocortin receptor agonist.

Investigated diseases

Vitiligo – Vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on various parts of the body. This occurs when the cells responsible for skin color, called melanocytes, are destroyed or stop functioning. The progression of vitiligo can vary, with some people experiencing slow changes over many years, while others may see rapid changes. The patches can appear on any part of the body, including the face, hands, and feet, and may spread over time. The condition can affect people of any age, gender, or ethnic group. The exact cause of vitiligo is not fully understood, but it is believed to involve genetic, autoimmune, and environmental factors.