Efficacy and Safety of Ruxolitinib Cream in Patients With Cutaneous Lichen Planus: A Randomized Clinical Trial
In brief
Ruxolitinib cream brought half of lichen planus patients to clear or near-clear skin
In this 64-person phase 2 trial, 50% using ruxolitinib cream had clear or nearly clear skin with substantial improvement at 16 weeks, compared with 22% using vehicle cream. A major itch improvement also occurred more often with ruxolitinib, and no serious treatment-related events or adverse-event withdrawals were reported. The small, short trial leaves longer-term safety and effectiveness uncertain.
- Journal
- JAMA dermatology (Q1)
- Published
- 23 September 2026
- Study design
- Phase 2 randomized trial (exploratory)
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Aaron R Mangold, Benjamin Lockshin, Zhihong Lai, Rong Rong, Haq Nawaz, Benjamin D Ehst
- PMID
- 42776548
- DOI
- 10.1001/jamadermatol.2026.3646
Why clinicians should know about it
- Picked for Dermatology (paper of the day, 25 September 2026): Phase 2 RCT of ruxolitinib cream for cutaneous lichen planus
Abstract
IMPORTANCE: Lichen planus is a chronic, highly pruritic, inflammatory disease that affects the skin and other tissues. OBJECTIVE: To evaluate the efficacy and safety of ruxolitinib, 1.5%, cream in patients with cutaneous lichen planus. DESIGN, SETTING, AND PARTICIPANTS: This phase 2, 16-week, randomized, double-blind, vehicle-controlled trial with a 16-week open-label extension was conducted from November 2022 to February 2024. Patients were enrolled from 19 sites in the US and Canada. The trial included adults with predominantly cutaneous lichen planus, an Investigator's Global Assessment (IGA) score of 3 or 4, an Itch Numerical Rating Scale score of 4 or greater, and an affected body surface area of 20% or less were enrolled. Data were analyzed from February to August 2024. INTERVENTIONS: Patients were randomized 1:1 to ruxolitinib, 1.5%, twice daily cream or vehicle cream for 16 weeks, after which eligible patients applied ruxolitinib cream twice daily as needed in a 16-week, open-label extension. MAIN OUTCOMES AND MEASURES: The primary end point was IGA treatment success (IGA score of 0 or 1 [clear/almost clear skin] with a ≥2-grade improvement from baseline) at week 16. RESULTS: Among 64 randomized patients, 46 (72%) were female, 18 (28%) were male, 18 (28%) were African American/Black, 4 (6%) were Asian, 40 (63%) were White, and the median (range) age was 57.0 (18-78) years. Significantly more patients who applied ruxolitinib, 1.5%, cream vs vehicle achieved IGA treatment success (50.0% [95% CI, 31.9%-68.1%] vs 21.9% [95% CI, 9.3%-40.0%], respectively; response rate difference, 29.4% [95% CI, 7.6%-51.3%]; P = .01; primary end point) at week 16, with further improvement to week 32. Similar results were observed in the proportion of patients who achieved a 4 or greater-point improvement from baseline in Itch Numerical Rating Scale score (week 16, 48.4% [95% CI, 30.2%-66.9%] vs 16.1% [95% CI, 5.5%-33.7%]; response rate difference, 33.5%; 95% CI, 12.2%-54.9%; P = .004; secondary end point). No serious treatment-emergent adverse events or discontinuations due to an adverse event were observed with ruxolitinib cream. CONCLUSIONS AND RELEVANCE: The results of this randomized clinical trial suggest that ruxolitinib cream significantly reduced lesions and itch in patients with lichen planus. Therefore, ruxolitinib cream represents a potential treatment option for patients with cutaneous lichen planus. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05593432.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.