Ruxolitinib in Seborrheic Dermatitis

Phase 2

Completed

Conditions: Seborrheic Dermatitis

Interventions: Drug: Ruxolitinib 1.5% Cream

Registration Number: NCT05787860

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ruxolitinib Cream	Ruxolitinib 1.5% Cream	Participants will receive topical ruxolitinib 1.5% cream

Primary Outcome Measures

Name	Time	Method
Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4	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

Secondary Outcome Measures

Name	Time	Method
Change in Investigator Global Assessment From Baseline to Week 4	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
Mean Change in Seborrheic Dermatitis Severity Score	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)
Mean Change in Seborrheic Dermatitis Severity Score for Scale	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)
Change in Seborrheic Dermatitis Severity Score for Erythema	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)
Change in Seborrheic Dermatitis Severity Score for Pruritus	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)
Frequency of Adverse Events	6 weeks
Duration of Adverse Events	6 weeks
Severity of Adverse Events	6 weeks	Severity will be measured as a category (mild, moderate, or severe).