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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Centre Hospitalier Universitaire De Nice	Nice	France
Oibncocw Ilalzzdolla	Rome	Italy

Trial status

Country	Status	Recruitment Start
France	Not recruiting	19.02.2024
Italy	Not recruiting	19.02.2024

Trial locations

Investigated drugs:

Afamelanotide

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.

Investigated diseases:

Vitiligo

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.

Trial ID:

2023-507470-40-00

Protocol code:

CUV105

NCT ID:

NCT06109649

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?