Clinical Trials
Clinical and Outcomes Research under the direction of the Department of Dermatology is conducted at the Northwestern University Feinberg School of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, and Northwestern Lake Forest Hospital dermatology clinics.
For more information about the research or participation, please call our office at 312-503-5944.
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DERMATOLOGY TISSUE ACQUISITION AND REPOSITORY Northwestern University’s Department of Dermatology is collecting skin, hair, nail, blood,
saliva, skin and/or buccal swabs, and mucous membrane(part of your skin which lines body
passages and cavities such as the inside of your mouth or nose), and ot… Northwestern University’s Department of Dermatology is collecting skin, hair, nail, blood,
saliva, skin and/or buccal swabs, and mucous membrane(part of your skin which lines body
passages and cavities such as the inside of your mouth or nose), and other tissue samples for use
in a biorepository. By operating this biorepository, the Department of Dermatology hopes to
develop a better understanding of skin diseases (meaning the knowledge about how cells in the
skin behave and react to medical treatments) among researchers at Northwestern University and
other approved researchers. This basic knowledge is expected to help the development of more
effective patient care and new treatment methods. -Having specimens collected as part of a standard of care procedure; -Have a skin disease which researchers want samples of in order to further understand it; or -Qualify as a healthy volunteer whose samples researchers can use as control samples for research.
STU00009443 |
Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis The aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.… The aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features. Subjects will receive 6 months of either Humira or Methotrexate.
18-75 years old with the diagnosis of moderate-to-severe plaque psoriasis; participants must be willing to have taken digital photographs of their plaque lesions and uninvolved skin; participants must not have not taken any systemic psoriatic therapy for at least 4 weeks before the start of the study and/or use of any topical treatments at least 2 weeks prior to start of the study. NCT02162472 STU00078102 |
Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) To evaluate the safety and effectiveness of the topical ointment (cream), SGX301, in combination with light therapy in patients with cutaneous T-cell lymphoma. Must be 18 years of age or older, with a clinical diagnosis of Cutaneous T- Cell Lymphoma, Myucosis Fungoides, Stage IA. Stage IB, or Stage IIA, and willing to refrain from sunbathing for duration of the study.
NCT02448381 STU00200530 |
AAD-PEPR: Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments The purpose of this study is to validate patient-reported outcomes (PRO) measures in three existing asthma intervention trials as well as a large group of itch-specific pediatric skin conditions, primarily focusing on a… The purpose of this study is to validate patient-reported outcomes (PRO) measures in three existing asthma intervention trials as well as a large group of itch-specific pediatric skin conditions, primarily focusing on atopic dermatitis (AD, or eczema). The study will look at how well Patient Reported Outcomes Measurement Information System (PROMIS) tools uncover meaningful changes in disease status as well as build a list of items relating to pediatric skin diseases and a PRO model for signs and symptoms of skin disease. STU00202292 |
Defining the Skin and Blood Biomarkers of Ichthyosis Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper… Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper understanding of this disease is required to develop better treatments. There are different types of cells and cell-produced signals (biomarkers) that are being studied in order to help find these new treatments. Looking at biomarkers has been successful in helping us to understand other skin disorders better. The purpose of this study is to determine which blood and skin biomarkers characterize ichthyosis in children. Subjects (1 year to 60 years of age) with Autosomal Recessive Congenital Ichthyosis (ARCI), which includes lamellar Ichthyosis, Netherton Syndrome, or other ichthyosis subtypes will be enrolled. Healthy control subjects will be enrolled for either a blood sample or skin sample, and/or tape strip samples. STU00203051 |
Joint Complaints in Children with Harlequin Ichthyosis: A Study to Assess for Comorbidity The goal of this study is to understand the pattern of joint pain and what pain management options or treatments have worked for individuals with joint disease related to Harlequin Ichthyosis (HI). Participatio… The goal of this study is to understand the pattern of joint pain and what pain management options or treatments have worked for individuals with joint disease related to Harlequin Ichthyosis (HI). Participation in the study will involve completing a one-time survey administered through letter mailing, emailing, link using an online survey, or in person at the Lurie Children’s Dermatology Clinic. The survey will take about 15-30 minutes. Confirmed diagnosis of Harlequin Ichthyosis (HI) and have complaints of joint pain, difficulty walking, swelling or other similar issues with your muscles and bones. STU00203185 |
Defining The Skin and Blood Biomarkers of Pediatric Atopic Dermatitis Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. A deeper understanding of this disease is required to develop new and better treat… Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. A deeper understanding of this disease is required to develop new and better treatments. There are different types of cells and cell-produced signals (biomarkers) that have been found in adults with AD. Nevertheless, there may be significant differences between AD in children versus adults. The purpose of this study is to determine which blood and skin biomarkers characterize AD in children by looking at the blood and skin biomarkers of children with AD and children without AD. This study will enroll children ages 0 months to 17 years to collect blood, skin, saliva and tape strip samples in order to look at biomarkers related to AD. Children who have or have not been diagnosed with AD or an atopic condition, such as allergies or asthma. STU00203272 |
A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL) The main goal of … The main goal of this study is to test the efficacy and safety of topical Naloxone for itching in patients with MF. 21 years of age or older with a diagnosis of mycosis fungoides (MF) with itching present on a daily basis for more than one month and willing to fill out a diary for 7 days to provide severity of itch before enrollment.
NCT02811783 STU00203078 |
A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Patients with Ichthyoses
Sub-Study: A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Maintenance Dosing Period to Evaluate the Efficacy and Safety of Secukinumab in Patients with Ichthyoses … This is a year-long study which will require monthly visits to the study site. The first four months will be double blind (you may receive either the study medication or placebo), then the remainder of the year participants will receive monthly injections of study medication. Participants must be 18 years of age or older, with a confirmed diagnosis of Autosomal Recessive Congential Ichthyosis (Lamellar Ichthyosis, Congential Ichthyosiform Erythroderma), Epidermolytic Ichthyosis, or Netherton's Syndrome, and at least moderate redness of the skin.
NCT03041038 STU00202022 |
A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. T… EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. These agents often have a side effect of an acne like rash that in some cases can be quite severe. This rash has been shown to be inflammatory in origin but is currently treated with antibiotics if it appears. The main goal of this study is to test if patients treated with steroid cream, (added) which is an anti-inflammatory medication, (added) before a rash develops have a less severe rash than patients who do not use a steroid cream before a rash develops. Must be 18 years of age or older with a diagnosis of cancer and starting an (changed from 'and') EGFR inhibitor. During the study you must be willing to fill out a daily diary, use sunscreen and cream daily, and fill out 2 questionnaires and have photographs taken every 2 weeks for 4 visits.
NCT03115567 STU00203631 |
Corrona Psoriasis Registry The main purpose of the Corrona Psoriasis registry is to learn more about psoriasis, how doctors treat psoriasis, how well medications and treatments work, and the safety of those treatments. To be eligible, you need to be 18 years of age or older, have been diagnosed with psoriasis by a dermatologist, and have started on or switched to a systemic biologic psoriasis treatment within the previous 12 months by a Northwestern dermatologist.
STU00203552 |
Gene Expression and Biomarker Profiling of Keloid Skin Sub-Study: A Pilot Trial of Keloid Genomic Profiling Using RNAseq Northwestern’s Department of Dermatology is performing a research study to better understand the causes of keloid scars. Keloid scars are solid tissue overgrowths that tend to d… Northwestern’s Department of Dermatology is performing a research study to better understand the causes of keloid scars. Keloid scars are solid tissue overgrowths that tend to develop after trauma to the skin. Subjects who are 18 years of age or older. Have no history of keloids or have a keloid on the earlobe or on another area of your body that either has not been treated or if treated, the treatment took place more than 6 months ago.
NCT03228693 STU00203462 |
An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS). Epidermolysis bullosa simplex (EBS) is a rare disorder that causes the skin to be… Epidermolysis bullosa simplex (EBS) is a rare disorder that causes the skin to be fragile. It is passed down from one or both parents, and the main signs are painful blisters that can become infected. The purpose of this study is to assess the safety and efficacy of an investigational topical (applied to the skin) ointment called Diacerein 1% for people with EBS. Enrollment in the study can be for up to 22 weeks and it will involve about 8 study visits to the site. At least 4 years of age with a clinical diagnosis and genetic mutation documented for epidermolysis bullosa simplex (EBS). Have EBS lesions that are greater than or equal to 2% body surface areas. The lesions need to be either generalized on the body or localized to the feet and palms. Patients with EBS lesions that are infected will be ineligible. NCT03154333 STU00205467 |
Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis Plaque psoriasis is a condition in which skin cells build up and itchy, dry patches and… Plaque psoriasis is a condition in which skin cells build up and itchy, dry patches and scales. The purpose of this study is to see how safe an investigational drug called ixekizumab for people with plaque psoriasis. This study is being done in two groups to understand how well ixekizumab will work to help people with plaque psoriasis. This study is also being done to get more information about the drug’s safety. Between the ages of 6 and 18 years of age with a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months. NCT03073200 STU00205002 |
Comparison of the efficacy between Cryolipolysis versus ATX-101 (Deoxycholic acid) for the treatment of upper back fat: a prospective randomized controlled pilot study The purpose of this study is to compare the effectiveness of cryolipolysis and ATX-101 (Deoxycholic acid)for the treatment of upper b… The purpose of this study is to compare the effectiveness of cryolipolysis and ATX-101 (Deoxycholic acid)for the treatment of upper back fat. Cryolipolysis, also known as fat freezing, is the treatment used to destroy fat cells by cooling the skin causing cell death of fat tissue without damaging overlying skin. ATX-101 an injectable that can destroy fat cells. Patients with mild to moderate upper back fat and currently living in the Chicago metropolitan area.
NCT03284034 STU00205070 |
(xIRB) A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects with Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE) Cutaneous lupus erythematosus (CLE) is a chronic autoimmune disorder, most commonl… Cutaneous lupus erythematosus (CLE) is a chronic autoimmune disorder, most commonly diagnosed in women 20-50 years of age. In CLE, the body’s immune system attacks the skin and causes rash and lesions (sores). This study will test an two experimental drugs called GS-9876 and filgotinib as a comparison drug for the treatment of CLE and a placebo. The subjects in this study will be randomly selected to enter into one of the three groups- those receiving GS-9876, filgotinib, or placebo. The purpose of this study is to see if filgotinib and/or GS-9876 are safe and effective for the treatment of your CLE. Females ≥18 to ≤ 75 years with a diagnosis of Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE).
NCT03134222 STU00205137 |
An Open-Label, Pilot Pharmacokinetic Study of INCB018424 Phosphate Cream in Pediatric Subjects With Atopic Dermatitis Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. The purpose of this study is to a… Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. The purpose of this study is to assess the safety of an investigational topical cream. Eligible study participants may attend up to 5 appointments over 12 weeks. This study will enroll children ages 12 to 17 years of age with active inflammation associated with AD. Subjects with an IGS score of at least 2 at screening and baseline visits. As well as with a BSA of AD involvement of 8%-20% at screening and baseline.
NCT03257644 STU00206246 |
A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogeneic stem cell transplantation (REACH 3) The purpose of the study is to find out if the drug ruxolitinib is safe and prov… The purpose of the study is to find out if the drug ruxolitinib is safe and provides better treatment in comparison with “Best Available Therapy” in people who have chronic (does not get better over time) Graft-versus-Host-Disease that does not get better with steroid medications Currently on steroids for GVHD post Allogenic Stem Cell Transplant.
NCT03112603 STU00206339 |
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly with Topical Corticosteroids in Patients, ≥6 YEARS TO <12 Years of Age, With Severe Atopic Dermatitis Atopic dermatitis (AD), also known as atopic eczema, is a skin di… Atopic dermatitis (AD), also known as atopic eczema, is a skin disease in which the skin is dry and scaly with severe itching that may continue despite treatment. The purpose of this study is to assess the efficacy and safety of dupilumab administered concomitantly with topical corticosteroids in patients ≥6 years to <12 years of age. This study will enroll children ages 6 to 12 years of age with active inflammation associated with AD with documented recent history of inadequate responses to topical AD medication(s). Subjects with an IGA score of 4 at screening and baseline visits. As well as with a BSA of AD involvement of ≥ 15% at screening and baseline.
NCT03345914 STU00207132 |
A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA (Protocol #RD.03.SPR.104003) This study is being done to … This study is being done to assess the efficacy and safety of two concentrations of Resuiqimod gel in the treatment of CTCL (stage IA, IB, IIA). In addition, this study will test the systemic effect of Resiquimod gel on lesions distant from the treatment areas. Must be 18 years or older with a clinical diagnosis of Cutaneous T Cell Lymphoma with at least three distinct lesions, including one distant lesion.
NCT03292406 STU00206325 |
Tralokinumab in combination with topical corticosteroids for
moderate-to-severe atopic dermatitis ECZTRA 3 is a study that will test if tralokinumab is better than placebo at treating moderate to severe atopic dermatitis. In this study, you will either get the study drug or a placebo. This will be ju… ECZTRA 3 is a study that will test if tralokinumab is better than placebo at treating moderate to severe atopic dermatitis. In this study, you will either get the study drug or a placebo. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis, itch and several other symptoms, as well as general health status and quality of life Age 18 and above with a diagnosis of moderate to severe atopic dermatitis > 1 year, and have had inadequate response to treatment with topical medication or for whom topical treatment are medically inadvisable.
NCT03363854 STU00206706 |