Treatment of vitiligo with ruxolitinib cream in the TRuE-V1 and TRuE-V2 studies: a plain language summary of publication

Abstract

Summary

What is this summary about?

• This is a summary of a research article published in a medical journal that describes the main results from two studies called TRuE-V1 and TRuE-V2

• These studies looked at the use of ruxolitinib cream to treat vitiligo, a long-term condition where white patches develop on the skin

• Ruxolitinib belongs to a group of medicines called Janus kinase (JAK) inhibitors, which have been shown to restore the skin color (also known as skin pigment) of some people with the most common form of vitiligo (non-segmental vitiligo, also known as generalized vitiligo or bilateral vitiligo)

What happened in the studies?

• Researchers who designed the TRuE-V1 and TRuE-V2 studies wanted to understand if ruxolitinib cream helped to restore the skin color of people with non-segmental vitiligo, compared with an identical cream that did not contain ruxolitinib. This is called a vehicle cream

• In the studies, people aged 12 years and older with non-segmental vitiligo were randomly chosen to apply either ruxolitinib cream or vehicle cream to the parts of their body affected by vitiligo twice a day for 6 months. For every one person that used the vehicle cream, two people used the ruxolitinib cream

• The main goal of the studies was to find out how many people had a 75% improvement in their facial vitiligo after 6 months

○ This meant that three-quarters of the white patches on the face returned to normal skin color

• Other goals included measuring:

○ How many people had a 50% improvement in the vitiligo on their whole body after 6 months

■ This meant that half of the white patches on the whole body returned to normal skin color

○ How many people felt their vitiligo was less noticeable after 6 months

• The study also looked at the side effects of ruxolitinib cream and the vehicle cream

What do the results mean?

• In both the TRuE-V1 and TRuE-V2 studies, people who used ruxolitinib cream for 6 months had greater improvements in their vitiligo compared with those who used the vehicle cream

• The most common side effects were acne (red pimples located mainly on the face) and itchy skin where ruxolitinib cream was applied

• Results from the studies suggest that ruxolitinib cream helps to restore the color of the skin over time in people with non-segmental vitiligo

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