Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

NCT ID: NCT06684522

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eyelid Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Upadacitinib Treatment

Participants on upadacitinib 15mg daily

Group Type EXPERIMENTAL

Upadacitinib 15 MG

Intervention Type DRUG

Upadacitinib 15mg daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Upadacitinib 15 MG

Upadacitinib 15mg daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RINVOQ

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Walter Liszewski

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Walter Liszewski

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dermatology CTU

Role: CONTACT

312-503-5944

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dermatology CTU

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00221561

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cyclosporin Implant to Treat Uveitis
NCT00001737 COMPLETED PHASE1
Treating Lid Wiper Epitheliopathy
NCT06671041 COMPLETED PHASE4