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Recruiting NCT06684522

Upadacitinib as a Novel Treatment for Refractory Eyelid Dermatitis

Early Phase I Interventional Eyelid Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upadacitinib 15 MG.
Who it may be relevant to
Registry conditions: Eyelid Dermatitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug Upadacitinib 15 MG
    Upadacitinib 15mg daily

Primary outcome measures

  • Reduction in Investigator Global Assessment (IGA) [Time frame: 12 weeks]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern University Department of Dermatology — Chicago

Identifiers

NCT: NCT06684522 · STU00221561

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗