Does your child have vitiligo?
Find out more about our study of a cream for children designed to reduce vitiligo symptoms and slow progression
The TRuE-ViP Study is testing how safe and effective a study cream called ruxolitinib may be in treating children younger than 12 years old with vitiligo on the face and body.
Ruxolitinib is approved in the United States, European Union, and United Kingdom to treat vitiligo in adults and adolescents 12 years of age or older. However, there are no similarly approved treatments for children younger than 12 years of age.
Participants may receive:
- Access to an investigational study cream designed to reduce vitiligo symptoms
- Close study-related care and monitoring from a vitiligo specialist
- Compensation for time and travel expenses
To join the study, a child must:
- Be 2 to 11 years old
- Have been diagnosed with nonsegmental vitiligo
- Not have more than 10% of their face and body affected by their condition (will be confirmed by study doctor)
Other requirements need to be met to join the TRuE-ViP Study.
Participation in the TRuE-ViP Study may last up to 14 months, involves a total of 11 visits and includes the following:
- Screening: Up to 30 days
- Treatment period: 52 weeks
- Follow-up: 30 days after the last application of the study cream
After screening, children who are eligible to take part in the study will begin the 52-week treatment period. During the first 24 weeks of the treatment period, children will be randomly assigned (like flipping a coin) to receive either the study cream or another cream that does not have any active ingredients. Depending on the child’s age, either they or a parent/guardian will apply the cream to affected areas on the face and body of the child twice a day.
Participants who complete 24 weeks of treatment without side effects will move on to a 28-week extended treatment period during which all participants will receive the study cream for twice daily application.
Vitiligo is a condition where the skin loses its color in patches, causing white spots to appear. The condition affects up to 2% of the population worldwide.
A cream called ruxolitinib is approved in the United States, European Union, and United Kingdom to treat vitiligo in adults and adolescents 12 years of age or older. However, there are no similarly approved treatments for children younger than 12 years of age.
The TRuE-ViP Study is being done to learn how well ruxolitinib cream works in treating vitiligo on the face and body of children aged over 2 years but under 12 years.
A clinical trial is a research study that evaluates potential new treatment options for patients. Most medications, treatments, medical devices, and tools used in the medical field today started in a clinical trial. The regulatory agencies must review the results from clinical trials before approving a medication, treatment, or medical device. Participants in clinical trials must meet specific criteria to participate and can withdraw from a study at any time.
Frequently asked questions
The TRuE-ViP Study is testing how safe and effective a study cream may be in treating children younger than 12 years old with vitiligo on the face and body.
Participation in the TRuE-ViP Study may last up to 14 months, involves a total of 11 visits and includes the following:
- Screening: Up to 30 days
- Treatment period: 52 weeks
- Follow-up: 30 days after the last application of the study cream
After screening, children who are eligible to take part in the study will begin the 52-week treatment period. During the first 24 weeks of the treatment period, children will be randomly assigned (like flipping a coin) to receive either the study cream or another cream that does not have any active ingredients. Depending on the child’s age, either they or a parent/guardian will apply the cream to affected areas on the face and body of the child twice a day.
Participants who complete 24 weeks of treatment without side effects will move on to a 28-week extended treatment period during which all participants will receive the study cream for twice daily application.
Joining the TRuE-ViP Study is completely up to you. Deciding not to allow your child to take part will not affect their usual medical care now or in the future. If your child does take part in the study, you may decide to remove them from the study at any time and for any reason.
During a clinical study, your child may receive the medication (in the TRuE-ViP study it is a cream) being studied. If your child participates, they may also have some of the following procedures performed to monitor their health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study cream. In some studies, participants may receive a placebo, which looks like the medication being tested but doesn’t have any active ingredients. All study volunteers are always closely monitored by clinic staff and the medical team to ensure their safety.
In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
Participation in any clinical study is completely voluntary. Your decision to allow your child to participate – or not participate – in this clinical study will have no effect on the medical care that they receive now or in the future. If your child is eligible and you choose to allow them to participate in the study, you may withdraw them from the clinical study at any time, and for any reason.
Incyte Corporation will reimburse all study participants for study-related travel and expenses. For more information, please speak with a member of the study team during your study visits.
You’ll first be asked some general questions (here) that help us determine whether your child meets the basic criteria of the study. If they do meet this criteria, you may be asked to come in for a study visit. At that visit, your child will be screened to see if they fit the specific qualifications for the study.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving a new treatment for an ongoing disease or condition. Participants also play an important part in bringing much needed drugs to market, benefitting thousands of people who also have the disease or condition. In many cases, this can be life changing. In addition to benefitting those with the disease, participants may be paid for their time and travel expenses.
Participants like you really help make a difference. (See if you pre-qualify for this research study.)
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to discontinue your child’s participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which your child is otherwise entitled to.
Incyte Corporation is responsible for conducting this clinical study.
