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.

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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
Investigator Global Assessment of 0 or 1 at Week 4	At end of Treatment, 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 seborrheic dermatitis severity score from baseline to week 6	Baseline to 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)
Change in seborrheic dermatitis severity score from week 4 to week 6	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)
Duration of Adverse Events	Baseline to Week 6
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
Change in seborrheic dermatitis severity score from baseline to week 4	Baseline and Week 4	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)
Change in seborrheic dermatitis severity score for Erythema from baseline to week 4	Baseline and Week 4	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 from baseline to week 4	Baseline and Week 4	Pruritus 0-4, where higher scores indicate more severe outcomes.; (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Severity of Adverse Events	Baseline to Week 6	Severity will be measured as a category (mild, moderate, or severe).
Change in seborrheic dermatitis severity score for Scale from baseline to week 4	Baseline and Week 4	Scale 0-4, where higher scores indicate more severe outcomes.; (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Frequency of Adverse Events	Baseline to Week 6

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States