Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

Early Phase 1

Not yet recruiting

• Conditions: Eyelid Dermatitis
• Interventions: Drug: Upadacitinib 15 MG

• Registration Number: NCT06684522
• Lead Sponsor: Northwestern University

Brief Summary

This study aims to assess the efficacy of upadacitinib in eyelid dermatitis that has not resolved with topical therapies and patch testing.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-10
• Study First Submitted QC: 2024-11-10
• Last Update Submitted: 2024-11-10
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Study Start: 2024-12
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Individuals age 18-70 years old with eyelid dermatitis for at least two months
• Failure of at least one topical prescription cream for the eyelid dermatitis (steroid, pimecrolimus, tacrolimus, crisaborole, or ruxolitinib)
• Women of reproductive potential must agree to using effective contraception during treatment and for 4 weeks following the final dose of Upadacitinib.
• Willing and able participants that provide informed consent
• Willing and able participants that comply with study activities

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Exclusion Criteria

• Self-reported history of allergic response to upadacitinib
• Subject with self-reported history of heart disease, stroke, or neurological conditions
• Currently taking topical medications for eyelid dermatitis within one week of starting study drug
• Women who are pregnant, nursing, or who may become pregnant during the study
• Non-English-speaking subjects
• Patients with an active serious infection
• Patients with active TB or latent TB, patients should be tested for TB prior to upadacitinib treatment.
• Patients with active HBV/HCV or abnormal lab ranges, Lab Data: Hb<8g/dL, ALC<500 cells/mm3 and ANC <1000 cells/mm3
• Patients with a history of malignancy within the last 5 years other than successfully treated NMSC.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Upadacitinib Treatment	Upadacitinib 15 MG	Participants on upadacitinib 15mg daily

Primary Outcome Measures

Name	Time	Method
Reduction in Investigator Global Assessment (IGA)	12 weeks	Reduction in baseline IGA score at week 12 compared to week 0

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States