NCT05787860

Ruxolitinib in Seborrheic Dermatitis

Characterizing the Molecular Cutaneous Phenotype of Seborrheic Dermatitis and Treatment Response to Ruxolitinib 1.5% Cream

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label prospective interventional trial that will assess the efficacy of ruxolitinib in the treatment of seborrheic dermatitis. It will also attempt to characterize the molecular immune profiles of patients with SD at week 0 and week 4, with comparison to baseline profiles in healthy control subjects.

Detailed description

The study will include 25 adult patients with moderate-to-severe-SD as well as 20 age- and gender-matched healthy control subjects for comparison. The SD patients will have baseline clinical score of at least 6 using the SD Severity Score in Appendix 1, or an Investigator Global Assessment (IGA) score of at least 3. Enrolled SD subjects will apply topical ruxolitinib 1.5% cream twice daily for 4 weeks. They will return for visits at weeks 2, 4, and 6 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and monitoring for adverse events.

Conditions

• Seborrheic Dermatitis

Interventions

Type	Name	Description
DRUG	Ruxolitinib 1.5% Cream	topical ruxolitinib 1.5% cream twice daily for 4 weeks

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-01-26
• Completion: 2024-01-26
• First posted: 2023-03-28
• Last updated: 2025-05-06
• Results posted: 2025-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study