A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
This research study is testing a cream called ruxolitinib on children between 6 and 11 years old who have nonsegmental vitiligo. Vitiligo causes white patches on the skin. The study aims to find out if this cream can help bring back colour to these patches and if it is safe for children to use. Participants will use either the ruxolitinib cream or a cream without the active medicine (a 'vehicle cream') to see which is more effective. This is a common way to compare new treatments. The study will carefully check how children respond to the cream and if they experience any side effects.
במבט חטוף
על מה המחקר הזה?
Vitiligo is a skin condition where patches of skin lose their colour, creating white areas. In this study, doctors are focusing on a type called nonsegmental vitiligo in children aged 6 to 11. They want to see if a cream called ruxolitinib can help bring back the natural skin colour to these white patches.
The research involves comparing ruxolitinib cream with a 'vehicle cream'. This vehicle cream looks just like the ruxolitinib cream but doesn't contain the active ingredient. This comparison helps the researchers understand if any improvements are genuinely due to the study cream or if they might happen anyway.
The main goal is to check how well the ruxolitinib cream works (its 'efficacy') and if it's safe for children to use. Doctors and medical staff will regularly check on the children taking part to monitor their skin, record any changes, and make sure they are feeling well throughout the study.
נקודות עיקריות
- This study tests a new cream (ruxolitinib) for children with vitiligo.
- It's for children aged 6 to 11 with nonsegmental vitiligo.
- The study compares ruxolitinib cream with a plain 'dummy' cream.
- It aims to check how well the cream works and if it's safe.
- Participation involves regular clinic visits and stopping other vitiligo treatments.
מי עשוי להיות זכאי?
To join this study, children need to be between 6 and 11 years old and have a specific type of vitiligo called nonsegmental vitiligo. They need to have a certain amount of white patches on their face and body, but not too much overall. There also needs to be some coloured hair within the white patches on their face.
There are also some reasons why a child might not be able to join. For example, if they have other types of vitiligo or other skin conditions that could look similar. Children who have recently used other vitiligo treatments, or who have certain other health issues or serious illnesses, might not be suitable. Also, if a child's weight is very low or very high for their age, they would not be able to participate. It's important that any child joining the study can follow the study instructions and attend all appointments.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Is your child aged between 6 and 11 years old?
- Does your child have nonsegmental vitiligo?
- Does your child have some white patches on their face and body (but not too much overall)?
- Are there some coloured hairs within the white patches on their face?
- Could your child attend all scheduled study appointments?
מה כרוך בהשתתפות?
If your child takes part, they will receive either the ruxolitinib cream or a cream without the active medicine (the 'vehicle cream') to apply to their skin. The study will involve regular visits to the clinic where doctors and nurses will check your child's skin, look for changes in the white patches, and ask about how they are feeling. They will also carry out assessments to monitor your child's general health.
During the study, your child will need to stop using any other treatments for vitiligo. You will be given clear instructions on how and when to apply the cream. There will also be a follow-up period after your child finishes using the cream to make sure they are still well. The total length of time your child will be involved in the study, including all visits and the follow-up, will be explained in full detail by the study team.
סיכונים ותועלות פוטנציאליים
Locations (78)
- Psoriahueמיקוד מאומתבואנוס איירס, ארגנטינה· גיוס
- Hospital Italiano de Buenos Airesמיקוד מאומתבואנוס איירס, ארגנטינה· גיוס
- Instituto de Neumonologia Y Dermatologiaמיקוד מאומתבואנוס איירס, ארגנטינה· גיוס
- Consultorios Medicos Dr. Doreskiמיקוד מאומתבואנוס איירס, ארגנטינה· גיוס
- Derma Internacional S.A.מיקוד מאומתבואנוס איירס, ארגנטינה· גיוס
- Hospital Universitario Australלא מאומתDerqui-pilar, Argentina· גיוס
- Centro de Investigaciones Medicas Mar Del Plataמיקוד מאומתMar del Plata, Argentina· גיוס
- Hospital Del Nino Jesusמיקוד מאומתסן מיגל דה טוקומאן, ארגנטינה· גיוס
- Universitaetsklinikum Grazמיקוד מאומתגראץ, אוסטריה· גיוס
- Medical University Innsbruckמיקוד מאומתאינסברוק, אוסטריה· גיוס
- Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)מיקוד מאומתבריסל, בלגיה· גיוס
- Universitair Ziekenhuis Gentמיקוד מאומתגנט, בלגיה· גיוס
שאלות נפוצות
What is nonsegmental vitiligo?
It's a common type of vitiligo where white patches can appear on both sides of the body and often spread over time.
What is ruxolitinib cream?
It's a skin cream being tested to see if it can help bring back colour to vitiligo patches.
Will my child definitely get the new cream?
No, your child might get the active cream or a cream that looks the same but doesn't contain the medicine, so it's a 50/50 chance.
Can my child use other vitiligo treatments during the study?
No, if your child joins the study, they will need to stop all other vitiligo treatments.
How long will my child be in the study?
The study team will explain the exact duration, which includes regular visits and a follow-up period after treatment ends.
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