Ruxolitinib Cream for Vitiligo

This trial tests a cream called ruxolitinib to determine its safety and effectiveness in treating nonsegmental vitiligo in children. Vitiligo causes patches of skin to lose color. Participants will receive either the ruxolitinib cream or a placebo (a cream with no active ingredient) to compare results. Ideal candidates for this trial have nonsegmental vitiligo, including noticeable patches on the face and other body parts, and are willing to stop other vitiligo treatments during the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for vitiligo.

The trial requires participants to stop using all treatments for vitiligo from the start of the study until the final safety follow-up visit.

Studies have shown that ruxolitinib cream is generally well tolerated, with most people not experiencing serious side effects. Some users might notice mild reactions at the application site, such as redness or itchiness. Importantly, significant side effects affecting the whole body have not been reported.

Research indicates that the cream is safe for treating vitiligo, a condition that causes skin to lose its color. While the safety of ruxolitinib cream for children under 12 with vitiligo is still under investigation, it has been used safely for other skin conditions like atopic dermatitis.

Ruxolitinib cream is unique because it targets the Janus kinase (JAK) pathway, which plays a key role in the immune response related to vitiligo. Unlike current treatments like corticosteroids or calcineurin inhibitors, which can have significant side effects with long-term use, ruxolitinib cream may offer a more targeted approach with potentially fewer side effects. Researchers are excited about this treatment because it could provide a more effective and safer option for repigmenting skin affected by vitiligo.

Research has shown that ruxolitinib cream can effectively treat vitiligo, a condition where the skin loses its color. In this trial, participants will receive either ruxolitinib 1.5% cream or a vehicle cream without active medication. Two studies found that people using ruxolitinib cream experienced more skin color return than those using a cream without medicine. Specifically, about 30% of people using ruxolitinib cream saw a 75% improvement in their facial vitiligo after six months. This suggests that ruxolitinib cream could be a promising option for restoring skin color in people with vitiligo.⁶⁷⁸⁹¹⁰