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Ruxolitinib cream monotherapy for facial and/or neck atopic dermatitis: results from a decentralized, randomized phase 2 clinical trial.

The Journal of dermatological treatment2025-03-26PubMed
Total: 72.0Innovation: 6Impact: 6Rigor: 9Citation: 6

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