Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo

This research study, called CUV105, is investigating a new way to treat vitiligo, a skin condition that causes white patches. Researchers want to see if combining a medication called afamelanotide (given as a small implant under the skin) with a type of light therapy (Narrow-Band Ultraviolet, or NB-UVB light) is more effective and safe than using only NB-UVB light. The study specifically focuses on vitiligo patches on the body and face. This is a Phase 3 trial, meaning it's one of the final steps before a treatment might be made widely available. It's designed to help doctors understand the best ways to help people living with vitiligo.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Clinuvel, Inc.

Enrolment target

200

Start

11 Oct 2023

Estimated completion

01 Jun 2026

Vitiligo

What is this study about?

Vitiligo is a condition where your immune system mistakenly attacks the cells that give your skin its colour (melanocytes), leading to white patches on your skin. This study is exploring a potential new treatment approach. It's called CUV105 and it's looking at whether a combination of treatments could work better than one treatment alone.

The main aim is to see if a small implant containing a medicine called afamelanotide, when used alongside a type of light treatment called Narrow-Band Ultraviolet B (NB-UVB) therapy, can help re-colour the skin patches more effectively and safely than using just the NB-UVB light therapy on its own. NB-UVB therapy is a common treatment for vitiligo, using specific wavelengths of light to stimulate pigment cells.

Researchers will be carefully watching how well people's skin re-pigments (gets its colour back) on both their body and face, and they'll also be checking for any side effects. This study is important because it could lead to better treatment options for people with vitiligo, offering new hope for managing the condition.

Key takeaways

The study is testing a new combination treatment for vitiligo.
It compares an implant plus light therapy against light therapy alone.
Participation involves regular clinic visits and monitoring.
You might get the new treatment or the standard treatment.
It's a chance to access potential new treatments and help medical research.
You can stop participating at any time.

Who may be eligible?

To join this study, participants generally need to be 12 years old or older and have been diagnosed with vitiligo that affects a certain amount of their body and face. Your skin type, known as Fitzpatrick skin types III to VI, is also important, which generally means your skin tends to tan easily or is naturally darker.

There are also reasons why someone might not be able to join. For example, if you have very fair skin (Fitzpatrick types I-II) or if you've recently had other light treatments for vitiligo within the last three months. You also can't have certain other skin conditions, a history of skin cancer, or severe liver problems.

For women, you cannot be pregnant or breastfeeding, and if you are able to have children, you must be using effective contraception. Similarly, men with partners who could become pregnant also need to be using effective contraception. These rules are in place to make sure the study is as safe as possible for everyone involved.

Quick self-check

Are you 12 years old or older?
Do you have white patches from vitiligo on your body and face?
Does your skin tend to tan easily or is it naturally darker (Fitzpatrick types III-VI)?
Have you avoided light therapy for vitiligo in the last three months?
Are you NOT currently pregnant or breastfeeding, and using effective contraception if applicable?
Do you have any severe liver problems or a history of skin cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would either receive the afamelanotide implant along with NB-UVB light therapy, or you would receive only the NB-UVB light therapy. The specific treatment you receive would be decided by chance, like flipping a coin. You would have regular visits to the clinic for assessments, which might include skin examinations, taking photos of your vitiligo patches, and possibly blood tests.

Throughout the study, you'd be carefully monitored for how your vitiligo responds to the treatment and for any side effects you might experience. The afamelanotide implant is a small device inserted under the skin, which would need to be done by a doctor. NB-UVB light therapy usually involves attending a clinic for short sessions a few times a week. The exact number of visits, assessments, and the total duration would be explained in detail by the study team, but typically, these kinds of studies can last for several months to over a year, followed by a follow-up period.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment approach for vitiligo before it's widely available, which might improve your skin's colour. However, as with any medical study, there are potential risks, including side effects from the treatments (such as skin irritation from light therapy or issues related to the implant) or that the treatment may not work for you. It's important to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

CLINUVEL site
Birmingham, United States
CLINUVEL site
Fresno, United States
CLINUVEL site
Los Angeles, United States
CLINUVEL site
Palo Alto, United States
CLINUVEL site
San Diego, United States
CLINUVEL Site
Washington D.C., United States
CLINUVEL site
Miami, United States
CLINUVEL site
Miramar, United States
CLINUVEL site
Alpharetta, United States
CLINUVEL site
Augusta, United States
CLINUVEL site
Chicago, United States
CLINUVEL site
Baton Rouge, United States

+18 more sites — see the official record for the full list.

Common questions

What is vitiligo?

Vitiligo is a long-term skin condition where patches of skin lose their colour, appearing as white spots. This happens when the cells that make skin pigment stop working or are destroyed.

What is NB-UVB light therapy?

NB-UVB light therapy is a common treatment for vitiligo. It uses a special type of ultraviolet light to stimulate pigment-producing cells in the skin to help bring back some colour.

What is afamelanotide?

Afamelanotide is a medicine given as a small implant under the skin. It's being studied to see if it can help stimulate pigment cells and work with light therapy to treat vitiligo.

Will I definitely get the new treatment if I join?

No, participants are randomly assigned to either receive the new treatment combination (afamelanotide + NB-UVB) or the standard treatment (NB-UVB alone). You won't get to choose which group you are in.

How long does the study last?

The full duration of the study, including treatment and follow-up, will be explained in detail by the study team. It typically involves regular visits over several months to over a year.