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Clinical Trials

Clinical and outcomes research under the direction of the Department of Dermatology is conducted both at the Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago dermatology clinics. For more information about the research or participation, please call our office at 312-503-5944.

Feinberg Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Learn more about our work via the Feinberg Office of Research Clinical Trials page.

Trials

DERMATOLOGY TISSUE ACQUISITION AND REPOSITORY

This study is collecting skin, hair, nail, blood,saliva, skin and/or buccal swabs, and mucous membrane (part of your skin which lines bodypassages and cavities such as the inside of your mouth or nose), and other tissue samples for usein a biorepository. By operating this biorepository, the Department of …
This study is collecting skin, hair, nail, blood,saliva, skin and/or buccal swabs, and mucous membrane (part of your skin which lines bodypassages and cavities such as the inside of your mouth or nose), and other tissue samples for usein a biorepository. By operating this biorepository, the Department of Dermatology hopes todevelop a better understanding of skin diseases (meaning the knowledge about how cells in theskin behave and react to medical treatments) among researchers at Northwestern University andother approved researchers. This basic knowledge is expected to help the development of moreeffective patient care and new treatment methods.
Eligibility Criteria
  • Consent to have specimens collected as part of a standard of care procedure
  • Have a skin disease diagnosis which researchers want samples of in order to further understand the disease
  • Qualify as a healthy volunteer (a person with no skin disease)
Principal InvestigatorRangel, Stephanie MarieRangel, Stephanie Marie
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
IRB number STU00009443
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Epidermolysis Bullosa Clinical Characterization and Outcomes Database

The aim this study is to collaboratively advance knowledge about epidermolysis bullosa (EB) by collecting clinical data from patients with EB from multiple EB centers in the United States and Canada. As EB is a rare disease, coordination and collaboration between multiple centers will help our understanding of disease manifestations, …

The aim this study is to collaboratively advance knowledge about epidermolysis bullosa (EB) by collecting clinical data from patients with EB from multiple EB centers in the United States and Canada. As EB is a rare disease, coordination and collaboration between multiple centers will help our understanding of disease manifestations, course, and complications, with the aim of improving future care, expanding clinical and translational research, and finding an eventual cure for individuals with EB.

Eligibility CriteriaAll candidates with a clinical diagnosis of epidermolysis bullosa are eligible for this study.  The subjects can be from any age, male or female without restriction.
Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 225 E. Chicago Ave.
    Chicago, IL
IRB number STU00202682
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The Gut and Skin Microbiome in Vitiligo Disease Progression

Volunteers are needed for a study on the microbiome of subjects with and without vitiligo. For patients with vitiligo and without vitiligo, the study will include an initial visit, at which time samples of the skin and swab samples of stool will be collected. All subjects will be asked to …

Volunteers are needed for a study on the microbiome of subjects with and without vitiligo. For patients with vitiligo and without vitiligo, the study will include an initial visit, at which time samples of the skin and swab samples of stool will be collected. All subjects will be asked to complete questionnaires about their skin care regimen and dietary habits.

Eligibility CriteriaVolunteers over the age of 18 are eligible to participate. Study is recruiting those with and without vitiligo.
Principal InvestigatorLe Poole, I. CarolineLe Poole, I. Caroline
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
IRB number STU00206844
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Characterization of the microbiome in cutaneous T cell lymphoma

The purpose of this study is to investigate the organisms that reside on the skin, in the gut, and nasal cavity and study their relationship with Cutaneous T-Cell Lymphoma (CTCL).
Eligibility Criteria
  • Be between the ages of 18-89
  • Be able and willing to provide informed consent
  • You must not have cutaneous t-cell lymphoma (CTCL)
  • You must not be currently pregnant
  • You must not be on or exposed to systemic antibiotics with 4 weeks of beginning study participation
Principal InvestigatorZhou, AlanZhou, Alan
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
IRB number STU00209226
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A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

The purpose of this research is to observe patients with skin conditions in a ‘real world’ setting and to create an patient registry of skin conditions, to better understand these diseases and how they are treated. A patient registry is a collection of information about a group of patients who …

The purpose of this research is to observe patients with skin conditions in a ‘real world’ setting and to create an patient registry of skin conditions, to better understand these diseases and how they are treated. A patient registry is a collection of information about a group of patients who share a condition or experience.

Additionally, researchers are interested in:

  • Observing how skin condition treatments work and understand side effects caused by these medicines and how these are managed
  • Identifying other types of conditions associated with skin disorders
  • Collecting patient reported outcomes to better understand the patient perspective and feelings patients have about having a skin condition
  • Assessing the impact of Patient Support Programs for individuals with skin conditions and how these programs affect skin condition outcomes
  • Creating a “Biorepository Specimen Bank” with blood and saliva samples

Eligibility Criteria
  • Have a skin condition such as Atopic Dermatitis, Psoriasis, Alopecia, Vitiligo, Hidradenitis Suppurativa and others.
  • You will not be asked to take any medications as part of this study.
Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 225 E. Chicago Ave.
    Chicago, IL
IRB number STU00209616
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Certolizumab in Pediatric Participants with Moderate to Severe Chronic Plaque Psoriasis

Patients age 6-17 years old with moderate to severe plaque psoriasis with at least one of: facial/scalp, genital, palm/sole, axillary involvement, candidate for systemic treatment or photo therapy or photochemotherapy.…

Patients age 6-17 years old with moderate to severe plaque psoriasis with at least one of: facial/scalp, genital, palm/sole, axillary involvement, candidate for systemic treatment or photo therapy or photochemotherapy.

Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
  • Map it 225 E. Chicago Ave.
    Chicago, IL
ClinicalTrials.gov IdentifierNCT04123795IRB number STU00211085
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Email Lu, Linda Phone
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Tape Strip Analysis in Dermatologic Diseases

The main purpose of this study is to better understand the characteristics of various dermatologic diseases compared to healthy controls. The research team will do this by acquiring tape strips from subjects, a quick, painless, and non-invasive way to obtain skin cells. This study will collect tape strip samples …
The main purpose of this study is to better understand the characteristics of various dermatologic diseases compared to healthy controls. The research team will do this by acquiring tape strips from subjects, a quick, painless, and non-invasive way to obtain skin cells. This study will collect tape strip samples from a broad range of dermatologic diseases, which may include psoriasis, epidermolysis bullosa, atopic dermatitis, ichthyosis, and other rare conditions, in addition to healthy controls. 
Eligibility Criteria
  • Have a dermatologic disease such as psoriasis, epidermolysis bullosa, atopic dermatitis, ichthyosis, or other rare skin condition
  • Be a healthy volunteer (someone with no dermatologic disease)
Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 225 E. Chicago Ave.
    Chicago, IL
IRB number STU00213591
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A Prospective and Retrospective Clinical, Histological and Molecular Analysis of the Spectrum of Cutaneous Presentations in Adult Patients Admitted to the Hospital

The purpose of this study is to better characterize and understand the spectrum of skin disease evaluated in the inpatient hospital setting.…

The purpose of this study is to better characterize and understand the spectrum of skin disease evaluated in the inpatient hospital setting.

Eligibility Criteria

  • Be older than 18
  • Be admitted to Northwestern Memorial Hospital or evaluated in the Emergency Department for whom an inpatient dermatology consultation is requested.

Principal InvestigatorNguyen, CuongNguyen, Cuong
Location(s)
  • Map it 251 E. Huron St.
    Chicago, IL
IRB number STU00212714
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A phase 1, open-label, safety and dosing study of autologous desmoglein 3 chimeric autoantibody receptor T cells (DSG3-CAART) in subjects with active, anti-DSG3, mucosal-dominant pemphigus vulgaris

The purpose of this study is to determine the highest dose of the study drug that can be given safely to patients with pemphigus vulgaris. The study will test how the study drug affects desmoglein 3 (DSG3) autoantibody amounts in your body. DSG3 is responsible for holding together the cells …

The purpose of this study is to determine the highest dose of the study drug that can be given safely to patients with pemphigus vulgaris. The study will test how the study drug affects desmoglein 3 (DSG3) autoantibody amounts in your body. DSG3 is responsible for holding together the cells lining the inside of the mouth, nose, throat, eyelids and genitals, causing the painful blisters commonly seen in patients with pemphigus vulgaris. The study will also look at how long the study drug stays in your body, and if the study drug improves the symptoms that you are experiencing with the pemphigus vulgaris.

Eligibility Criteria
  • Must be at least 18 years of age
  • Have a confirmed diagnosis of mucosal-dominant pemphigus vulgaris or have a prior positive demoglein 3-ELISA result (a pemphigus vulgaris diagnostic tool) and confirmed by biopsy at the screening visit
  • Have pemphigus vulgaris that has previously been inadequately managed by at least one prior standard therapy
Principal InvestigatorZhou, AlanZhou, Alan
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
ClinicalTrials.gov IdentifierNCT04422912IRB number STU00214626
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Email Tocker, Chen Phone
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A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

This study is being done to evaluate the safety and tolerability of tapinarof cream, 1% in children and adolescents with plaque psoriasis. This study will also measure the quantity of the study drug in your blood, if any. The efficacy, how well the study drug works, will also be evaluated.…

This study is being done to evaluate the safety and tolerability of tapinarof cream, 1% in children and adolescents with plaque psoriasis. This study will also measure the quantity of the study drug in your blood, if any. The efficacy, how well the study drug works, will also be evaluated.

Eligibility Criteria
  • Be 2-17 years old
  • Have a clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months
  • Have involvement of plaque psoriasis on at least 3% of the body, excluding the scalp
Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 225 E. Chicago Ave.
    Chicago, IL
IRB number STU00216645
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Email Lu, Linda Phone
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Dupilumab to Improve Sleep and Itch in Children with Atopic Dermatitis

This research is being done to determine the impact of dupilumab on sleep in children suffering from AD. Dupilumab is an FDA approved drug that can improve your eczema, and is injected under the skin once every other week for patients weighing more than 30kg (about 66 lbs) or once …

This research is being done to determine the impact of dupilumab on sleep in children suffering from AD. Dupilumab is an FDA approved drug that can improve your eczema, and is injected under the skin once every other week for patients weighing more than 30kg (about 66 lbs) or once a month for patients weighing less than 30kg (about 66 lbs).

If you agree to take part in the study, you will complete a screening visit at a Lurie Children’s location, NMH, or Abbott Hall after which you will come to Lurie Children’s Hospital, NMH, or Abbott Hall for two scheduled overnight stays where sleep studies will be performed. The screening visit may be completed remotely, and a watch to be used in this study will be mailed to your address. The study drug will first be given at the end of the pre-treatment visit. During the pre-treatment study visit, you will be trained on how to inject the study drug at home.

During weeks 1-12, you will continue injections of the study drug at home. Your study doctor or staff may contact you virtually during this period to check-in.

Eligibility Criteria

-Participants, 6-17 years old at time of enrollment.

- Moderate to severe chronic AD inadequately controlled by topical treatment

- AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).

- Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥60

- Willing and able to comply with visits and study-related procedures.

- On stable regimens (consistent use 14 days before Day 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines.

Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 225 E. Chicago Ave.
    Chicago, IL
  • Map it 676 N. Saint Clair St. Suite 1600
    Chicago, IL
IRB number STU00217498
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Dupilumab for Managing Itch in Inflammatory Genetic Skin Disorders

This research is being done to determine the impact of dupilumab on itch in children and adults suffering from itch disorders. Dupilumab is an FDA approved drug for eczema. Dupilumab is injected under the skin once every other week for patients weighing more than 30kg (about 66 lbs.) or once …

This research is being done to determine the impact of dupilumab on itch in children and adults suffering from itch disorders. Dupilumab is an FDA approved drug for eczema. Dupilumab is injected under the skin once every other week for patients weighing more than 30kg (about 66 lbs.) or once a month for patients weighing less than 30kg (about 66 lbs.).

We expect that your child will be in this research study for about 2 years (26 months, or 104 weeks). There will be an observational period of 8 weeks, followed by a treatment period of 16 weeks in which your child will receive dupilumab. This may be followed by a 20-month long-term extension period for those who qualify and wish to continue.

Your child will attend up to seven (7) visits in person during the observation period and 16-week open label phase period. The screening visit will take approximately 3 hours, and all other in person visits will take approximately 1-2 hours to complete.

Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 225 E. Chicago Ave.
    Chicago, IL
IRB number STU00218484
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Development and Validation of an Ancillary Diagnostic Test for Mycosis Fungoides (SIGNAL MF)

As the number of available treatments for CTCL grow, there is a need to find a way to identify which treatment will work best for each subject. The goal of this study is to develop a test called a gene expression assay to see if the assay can predict treatment …

As the number of available treatments for CTCL grow, there is a need to find a way to identify which treatment will work best for each subject. The goal of this study is to develop a test called a gene expression assay to see if the assay can predict treatment success and/or failure in subjects with CTCL.

Eligibility Criteria

Patient who has a diagnosis of mycosis fungoides (MF).

Patient who is between 2-89 years of age.

Patient who is willing and able to provide new skin samples via superficial scraping at least one affected and non-affected body site.

Principal InvestigatorGuitart, JoanGuitart, Joan
IRB number STU00217977
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Combing topical imiquimod with local radiotherapy treatment of mycosis fungoides

The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) mycosis fungoides (MF). Subjects will be asked to use the imiquimod cream at designated lesions nightly for 5 consecutive days a week …

The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) mycosis fungoides (MF). Subjects will be asked to use the imiquimod cream at designated lesions nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with radiation treatment in 2 fractions of 4 Gy (units of radiation absorbed by the patient) (total 8 Gy) over 2 days to the same designated lesions. In addition, subjects will have two skin biopsies during the screening period and again at the same locations at week 8.

Eligibility Criteria

Patients must have confirmed stage IA-IIB mycosis fungoides, have failed at least one standard therapy for MF, have active, but stable disease for at least 6 months with 4 or more discrete lesions (with at least 2 lesions >50cm2 in area combined). Patients of child bearing potential must have a negative pregnancy test before enrolling on the study.

Principal InvestigatorZhou, AlanZhou, Alan
Location(s)
  • Map it 676 N. Saint Clair St. Suite 1600
    Chicago, IL
ClinicalTrials.gov IdentifierNCT05838599IRB number STU00218514
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Study to Evaluate Baricitinib in Pediatric Alopecia Areata

Patients ages 6-18 years old with alopecia areata for over 1 year with a current episode of hair loss greater than 6 months. Need to have greater than 50% scalp hair loss and tried/failed one treatment.

Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
  • Map it 225 E. Chicago Ave.
    Chicago, IL
IRB number STU00219756
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Hair Disorder Registry

The purpose of this study is to collect characteristic data from patients with medical conditions affecting hair health using medical records and surveys. The main benefit of being in this study is to provide future benefit to patients with acquired and congenital hair disorders and the providers who care for …

The purpose of this study is to collect characteristic data from patients with medical conditions affecting hair health using medical records and surveys.

The main benefit of being in this study is to provide future benefit to patients with acquired and congenital hair disorders and the providers who care for them by adding to our understanding of normal hair physiology, causes and mechanisms of disease, clinical and molecular features, natural history, and treatment outcomes.

Eligibility Criteria

12 years and older with primary or secondary involvement of hair follicle disease

Principal InvestigatorColavincenzo, Maria LColavincenzo, Maria L
Location(s)
  • Map it 676 N. Saint Clair St. Suite 1600
    Chicago, IL
IRB number STU00219310
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Medical and Patient Reported Outcomes in HS

The purpose of this study is to understand the characteristics, risk factors, comorbidities, treatments, and clinical outcomes of HS patients. Questionnaires are completed during standard-of-care dermatology visits at NMH.

Principal InvestigatorFlood, KelseyFlood, Kelsey
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
IRB number STU00220038
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Study to understand the safety and efficacy of an experimental oral drug for HS

This research is being done to test the safety and efficacy of the study drug, upadacitinib, compared to a placebo (a treatment with no active properties) for the treatment of HS patients. Upadacitinib has been approved for specific medical conditions, but not approved for HS. The use of the study …

This research is being done to test the safety and efficacy of the study drug, upadacitinib, compared to a placebo (a treatment with no active properties) for the treatment of HS patients. Upadacitinib has been approved for specific medical conditions, but not approved for HS. The use of the study drug is investigational (experimental) for the purposes of this study.

Eligibility Criteria

Eligible subjects will be individuals who are at least 12 years of age at screening with a diagnosis of HS for at least 6 months and failed to respond to or are intolerant to anti-TNF alpha therapy or one approved non-anti-TNF biologic therapy for HS. Subjects will have moderate to severe HS.

Principal InvestigatorLiszewski, Walter JosephLiszewski, Walter Joseph
Location(s)
  • Map it 676 N. Saint Clair St. Suite 1600
    Chicago, IL
ClinicalTrials.gov IdentifierNCT05889182IRB number STU00219369
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Topical Bacteriotherapy for Atopic Dermatitis

Age ≥12 years old with active atopic dermatitis within the last 3 months and lesional skin on extremities or trunk that is positive for S. aureus.

Principal InvestigatorPaller, AmyPaller, Amy
Location(s)
  • Map it 676 N. St. Clair St.
    Chicago, IL
ClinicalTrials.gov IdentifierNCT06504160IRB number STU00221328
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Email Lu, Linda Phone
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Study to understand the safety and efficacy of an experimental oral drug for alopecia areata

This research is being done to test the safety and efficacy of the study drug, upadacitinib, compared to a placebo (a treatment with no active properties) for the treatment of alopecia areata patients. Upadacitinib has been approved for specific medical conditions, but not approved for AA. The use of the …

This research is being done to test the safety and efficacy of the study drug, upadacitinib, compared to a placebo (a treatment with no active properties) for the treatment of alopecia areata patients. Upadacitinib has been approved for specific medical conditions, but not approved for AA. The use of the study drug is investigational (experimental) for the purposes of this study.

Eligibility Criteria

Eligible subjects will be individuals who are at least 18-64 years of age at screening with a diagnosis of AA with a current episode of hair loss less than 8 years. Subjects will have severe AA.

Principal InvestigatorColavincenzo, Maria LColavincenzo, Maria L
Location(s)
  • Map it 676 N. Saint Clair St. Suite 1600
    Chicago, IL
ClinicalTrials.gov IdentifierNCT06012240IRB number STU00220523
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Email Tocker, Chen Phone
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Selective Treatment of Oral Povorcitinib in Hidradenitis Suppurativa

Povorcitinib is an investigational drug that is being studied for use in the treatment of hidradenitis suppurativa . The purpose of this study is to compare the safety and effects of INCB054707 compared to a placebo in people with hidradenitis suppurativa (HS). We expect that you will be in this research …

Povorcitinib is an investigational drug that is being studied for use in the treatment of hidradenitis suppurativa . The purpose of this study is to compare the safety and effects of INCB054707 compared to a placebo in people with hidradenitis suppurativa (HS). We expect that you will be in this research study for about 14 months or 62 weeks. You will be expected to make about 15 visits to the study site.

Principal InvestigatorRiley, Julia MhlabaRiley, Julia Mhlaba
Location(s)
  • Map it 676 N. Saint Clair St. Suite 1600
    Chicago, IL
ClinicalTrials.gov IdentifierNCT05620836IRB number STU00221310
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