Ruxolitinib cream reduced lesions and itch in cutaneous lichen planus

Design

Phase 2, 16-week, randomised, double-blind, vehicle-controlled trial with open-label extension

Population

64 adults with predominantly cutaneous lichen planus, up to 20% body surface area

Primary outcome

Investigator's Global Assessment treatment success at week 16

Effect

50.0% vs 21.9% (difference 29.4%, 95% CI 7.6–51.3); itch response 48.4% vs 16.1%

Cutaneous lichen planus is chronic and intensely pruritic, and treatment options beyond topical corticosteroids are limited. This phase 2, vehicle-controlled trial randomised 64 adults with predominantly cutaneous lichen planus, moderate-to-severe disease and up to 20% body surface area affected, to ruxolitinib 1.5% cream twice daily or vehicle for 16 weeks.

Treatment success — clear or almost-clear skin with at least a two-grade improvement — was reached by 50.0% on ruxolitinib versus 21.9% on vehicle, a difference of about 29 percentage points. Itch response was similar in magnitude, and no serious adverse events or treatment discontinuations occurred.

This gives a topical, steroid-free option for limited cutaneous lichen planus where potent topical steroids are undesirable. It is phase 2 and off-label, in a small group with modest disease extent, so it reads as a promising addition rather than a settled first-line choice. The class carries a boxed warning familiar from topical JAK use, and the trial does not address widespread or mucosal disease.

• Treatment success (clear/almost clear with ≥2-grade improvement) reached 50.0% with ruxolitinib cream vs 21.9% with vehicle (difference 29.4%, 95% CI 7.6–51.3; p=0.01).
• A ≥4-point itch improvement was reached by 48.4% vs 16.1% (difference 33.5%; p=0.004).
• No serious treatment-emergent adverse events or discontinuations over 16 weeks.
• Consider it for limited cutaneous lichen planus where potent topical steroids are unsuitable; it is not studied for widespread or mucosal disease.

Why it matters

It offers a non-steroidal topical for a disease where clinicians often jump to systemic therapy for want of options.

Don't overread it

This was a small phase 2 trial in limited disease and is not an approved indication — it does not establish ruxolitinib cream for widespread or mucosal lichen planus.

The statistics, in plain English

The response-rate difference of 29 percentage points with a confidence interval that stays above zero (7.6–51.3) means the benefit over vehicle is unlikely to be chance, though the lower bound shows it could be modest. With 64 patients, the estimate is real but imprecise.

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