Ruxolitinib cream monotherapy for facial and/or neck atopic dermatitis: results from a decentralized, randomized phase 2 clinical trial.
Summary
In a decentralized, double-blind phase 2 trial (n=77), twice-daily 1.5% ruxolitinib cream achieved higher head/neck EASI-75 responses at Week 4 than vehicle (37.0% vs 17.4%) using blinded photographic assessments; treatment was well tolerated. After Week 4, all patients used as-needed ruxolitinib through Week 8.
Key Findings
- Randomized 2:1, double-blind, decentralized phase 2 trial with 77 patients (44.2% Black), baseline head/neck EASI 1.2.
- Week-4 head/neck EASI-75 responses favored ruxolitinib cream over vehicle (37.0% vs 17.4%) using blinded central photographic assessment.
- Ruxolitinib cream was well tolerated; all patients transitioned to as-needed use through Week 8.
Clinical Implications
Ruxolitinib cream is a reasonable option for facial/neck AD where steroid-sparing and tolerability are priorities; decentralized photo-based monitoring could facilitate access and adherence.
Why It Matters
Provides controlled evidence specific to the cosmetically sensitive face/neck areas using decentralized, blinded photographic assessments, supporting topical JAK inhibition in regions where tolerability and safety drive prescribing.
Limitations
- Short primary treatment window (4 weeks) and small sample size limit power and durability assessment.
- Low baseline head/neck EASI may constrain generalizability to more severe disease.
Future Directions
Larger, longer trials comparing ruxolitinib cream to active comparators on face/neck, with safety endpoints relevant to sensitive skin and skin of color, and real-world decentralized monitoring.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized, double-blind, vehicle-controlled trial with blinded central assessment.
- Study Design
- OTHER