A phase 2, 16-week, randomized, double-blind, vehicle-controlled trial (plus 16-week open-label extension) evaluated ruxolitinib 1.5% cream twice daily vs. vehicle in 64 adults with cutaneous lichen planus (IGA score 3–4, itch NRS ≥4, BSA ≤20%) at 19 US and Canadian sites (Nov 2022–Feb 2024).
At week 16, IGA treatment success (clear/almost clear skin with ≥2-grade improvement) was achieved by 50.0% of ruxolitinib cream patients vs. 21.9% with vehicle (difference 29.4%, 95% CI 7.6%–51.3%; P=.01); clinically meaningful itch reduction (≥4-point NRS improvement) was achieved by 48.4% vs. 16.1% (difference 33.5%, 95% CI 12.2%–54.9%; P=.004), with further gains through week 32.
Small sample size (n=64) limits generalizability; study was restricted to predominantly cutaneous lichen planus (IGA 3–4, BSA ≤20%), so results may not apply to mucosal or more extensive disease; the 16-week controlled phase is relatively short for a chronic condition.
Ruxolitinib 1.5% cream applied twice daily produced significant lesion clearance and itch relief compared to vehicle, with no serious adverse events or discontinuations, making it a promising topical option for adults with moderate-to-severe cutaneous lichen planus.
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