NCT05787860

Ruxolitinib in Seborrheic Dermatitis

Completed Phase 2 Results posted Last updated 6 May 2025

What this trial tests

Phase 2 trial testing Ruxolitinib 1.5% Cream in Seborrheic Dermatitis in 45 participants. Completed in 26 January 2024.

Timeline

15 November 2022

Primary endpoint
26 January 2024

26 January 2024

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	15 November 2022
Primary completion	26 January 2024
Estimated completion	26 January 2024
Sites	1 location across United States

Drugs / interventions tested

• Ruxolitinib 1.5% Cream — full drug profile →

Conditions studied

• Seborrheic Dermatitis — all drugs for Seborrheic Dermatitis →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Seborrheic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4 Primary · At end of Treatment, Week 4

Number of Participants with Investigator Global Assessment of 0 or 1 at Week 4 IGA Scale from 0-4 Clear 0 No signs of SD Almost Clear 1 Just perceptible erythema and just perceptible scaling Mild 2 Mild erythema and mild scaling Moderate 3 Moderate erythema and moderate scaling Severe 4 Severe erythema and severe scaling

Group	Value	95% CI
Ruxolitinib Cream	20

Change in Investigator Global Assessment From Baseline to Week 4 Secondary · Baseline and Week 4

IGA Scale from 0-4 Clear 0 No signs of SD Almost Clear 1 Just perceptible erythema and just perceptible scaling Mild 2 Mild erythema and mild scaling Moderate 3 Moderate erythema and moderate scaling Severe 4 Severe erythema and severe scaling

Group	Value	95% CI
Ruxolitinib Cream	-2.16	± 0.69

Mean Change in Seborrheic Dermatitis Severity Score Secondary · Baseline, Week 4, Week 6

Mean Change in seborrheic dermatitis severity score from baseline and week 4, baseline a d week 6 and week 4 and week 6 SD Severity Score (the sum of the three clinical features for a total score ranging from 0-12), where higher scores indicate more severe outcomes. Scale 0-4 Erythema 0-4 Pruritus 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

baseline and week 4

Group	Value	95% CI
Ruxolitinib Cream	-6	± 1.61

baseline and week 6

Group	Value	95% CI
Ruxolitinib Cream	-2.8	± 2.96

week 4 and week 6

Group	Value	95% CI
Ruxolitinib Cream	3.2	± 2.52

Mean Change in Seborrheic Dermatitis Severity Score for Scale Secondary · Baseline, Week 4, and Week 6

Mean Change in seborrheic dermatitis severity score for Scale from baseline and week 4, baseline and week 6, week 4 and week 6 Scale 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

baseline and week 4

Group	Value	95% CI
Ruxolitinib Cream	-1.56	± 0.87

baseline and week 6

Group	Value	95% CI
Ruxolitinib Cream	-0.56	± 1.29

week 4 and week 6

Group	Value	95% CI
Ruxolitinib Cream	3.2	± 2.52

Change in Seborrheic Dermatitis Severity Score for Erythema Secondary · Baseline, Week 4, and Week 6

Change in seborrheic dermatitis severity score for Erythema from baseline and week 4, baseline and week 6, week 4 and week 6 Erythema 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

baseline and week 4

Group	Value	95% CI
Ruxolitinib Cream	-2	± 0.76

baseline and week 6

Group	Value	95% CI
Ruxolitinib Cream	-1.04	± 1.06

week 4 and week 6

Group	Value	95% CI
Ruxolitinib Cream	0.96	± 0.98

Change in Seborrheic Dermatitis Severity Score for Pruritus Secondary · Baseline Week 4, and Week 6

Change in seborrheic dermatitis severity score for Pruritus from baseline and week 4, baseline and week 6, week 4 and week 6 Pruritus 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

baseline and week 4

Group	Value	95% CI
Ruxolitinib Cream	-2.44	± 0.71

baseline and week 6

Group	Value	95% CI
Ruxolitinib Cream	-1.2	± 1.12

week 4 and week 6

Group	Value	95% CI
Ruxolitinib Cream	1.24	± 0.97

Frequency of Adverse Events Secondary · 6 weeks

Group	Value	95% CI
Ruxolitinib Cream	0
Healthy Control Subjects	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. T Cell Immunosenescence in Inflammatory Skin Diseases: Pathogenesis and Therapeutic Targets.
   Liu C, Yang M, Xiao F, Zeng J. · · 2026 · PMID 42050386 · DOI 10.1111/acel.70527