Efficacy and safety of ruxolitinib cream in patients with lichen sclerosus: Results from a phase 2, randomized, double-blind, vehicle-controlled study.
Andrew T Goldstein, Zhihong Lai, Rong Rong et al.
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In 30 seconds
This phase 2 randomized controlled trial evaluated the efficacy and safety of 1.5% ruxolitinib cream in 61 adult women with anogenital lichen sclerosus. At week 12, 35.7% of patients using ruxolitinib cream achieved a ≥4-point improvement in Itch NRS compared to 40.0% in the vehicle group (P = .737), while the ruxolitinib group showed a significant reduction in Clinical Lichen Sclerosus Score (-5.79 vs -3.03; P = .019).
Key findings
- 35.7% of ruxolitinib cream users achieved a ≥4-point improvement in Itch NRS at week 12.
- 40.0% of vehicle group patients achieved a ≥4-point improvement in Itch NRS at week 12.
- Ruxolitinib cream resulted in a greater reduction in Clinical Lichen Sclerosus Score (-5.79 vs -3.03; P = .019).
- Application site reactions were infrequent, with no serious adverse events reported.
Why it matters
The study highlights a potential nonsteroidal treatment option for lichen sclerosus, a condition with limited effective therapies. Understanding the efficacy and safety of ruxolitinib cream can inform treatment decisions for affected patients.
What to keep in mind
Treatment duration was relatively short.