Une étude pour comparer l'efficacité et la sécurité de SCENESSE et de la lumière ultraviolette à bande étroite (NB-UVB) par rapport à la lumière NB-UVB seule chez les patients atteints de vitiligo

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.

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.