Clinical Research

The Clinical Research Division in the Department of Dermatology conducts ongoing studies of novel therapeutic agents. Established to explore new drugs, devices and therapies, the Clinical Research Division is dedicated to pioneering innovative breakthroughs in the field of dermatology. Housed within the Department of Dermatology, the Clinical Research Division has ample office space and a fully equipped lab dedicated to tissue acquisition and analysis, laser scanning confocal microscopy, and more.

Considering a grant submission? Complete the Intent to Submit Form. This form is used to identify and allocate resources for grant development. It is the first step in planning for the production of high quality, competitive grant applications. This form is used to identify and allocate resources for grant development.

CITI Training is required for all students and residents who are involved in research studies related to human subjects in the Department of Dermatology.  The online modules are required prior to a student or resident being added to a research study since the training date must be provided to the IRB. First-time users will need to create an account. After registration, choose the biomedical research group; all modules must be completed.  Please send a copy of your completion certificate to Josh Hill.

Current Studies

Atopic Dermatitis / Eczema

Atopic Dermatitis

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Atopic Dermatitis

Study Title: A Phase 1/2B study to investigate the safety and pharmacokinetics and efficacy of UCB1381 in participants with atopic dermatitis 

 

We are seeking adults diagnosed with Atopic Dermatitis to participate in a clinical trial. The purpose of this study is to investigate the safety and efficacy of an investigational drug called UCB1381 versus a placebo.

 

Study Length: Participation is expected to last up to 26 weeks. This study will require 16 study visits of which three visits will occur via phone. Participation involves a physical exam, completion of questionnaires, vital signs, medical history, Atopic Dermatitis assessment, 12-lead electrocardiogram (ECG), skin punch biopsy, chest x-ray, collection of blood, stool, and urine, five mandatory and one optional overnight stays, and administration of either placebo or test drug through intravenous (injection through vein, IV) route. 

 

Participant Requirements:

 

 

  • 18-65 years old
  • Overtly healthy

  • Must have diagnosis of Moderate to Severe Atopic Dermatitis that has been present for at least 12 months

  • BMI within the range 18 to 35kg/m2

 

Compensation: Research study participants may be compensated.

 

This study is being conducted by Dr. Paul Bigliardi at the University of Minnesota, Department of Dermatology. To learn more about this study and to see if you qualify, please contact the study coordinator [email protected] or 612-624-6718.

Dermatomyositis

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Dermatomyositis

Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis

We are conducting a research study on individuals with dermatomyositis. The purpose of this research study is to learn more about the safety and effectiveness of an investigational drug called Brepocitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Participant requirements:

  • Male and/or Female 18-75 years of age
  • Confirmation of dermatomyositis diagnosis
  • Attend 13 visits over 56 weeks
  • Other requirements, which the study team will review with you

This study is being conducted by Dr. David Pearson in the University Of Minnesota Department Of Dermatology. For additional information, please visit the study page on https://clinicaltrials.gov/ct2/show/NCT05437263

Alternatively, contact the study coordinator: 612-625-2624 or [email protected]

 

 

Dermatomyositis and Polymyositis

Study Title: A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care

We are conducting a research study on individuals with Dermatomyositis and Polymyositis with active muscle involvement. The purpose of this research study is to learn more about the safety and efficacy of an investigational drug called Enpatoran. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Participant requirements:

  •  18-75 years of age
  •  Diagnosis of Dermatomyositis or Polymyositis
  •  Attend 10 visits over 26 weeks
  •  Other requirements, which the study team will review with you

This study is being conducted by Dr. David Pearson in the University of Minnesota Department of Dermatology. For additional information, please visit the study page on http://clinicaltrials.gov/ NCT05650567

Alternatively, contact the study coordinator: 612-625-2624 or [email protected]

Hair Diseases / Alopecia

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Alopecia Areata

Study Title: 

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata

We are conducting a research study for children ages 6-17 with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability and efficacy of an investigational drug called Baricitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works for 136 weeks to areas affected by Alopecia Areata, including the scalp and eyelashes and eyebrows.

Participant requirements:

  • Children ages 6-17 who are in good health
  • Diagnosed with patchy Alopecia Areata for at least one year
  • A greater than 50% hair loss
  • Must be willing to stop using other types of medications to treat AA throughout the study
  • Other requirements, which the study team will review with you

This study is being conducted by Dr. Maria Hordinsky at the University of Minnesota Department of Dermatology. For additional information, please call the study coordinator: 612-625-2624 or email: [email protected]

 

Study Title: 

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Program to Evaluate the Efficacy and Safety of Upadacitinib in Adult Subjects With Severe Alopecia Areata

We are conducting a research study on individuals with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability, and efficacy of an investigational oral drug called Upadacitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works for 24 weeks on areas affected by Alopecia Areata.

Participant requirements:

  • Men and women, ages 18-64, who are in good health
  • Diagnosed with Alopecia Areata and have 50% or greater scalp hair loss
  • Must be willing to stop using other types of medications to treat AA throughout the study
  • Other requirements, which the study team will review with you

This study is being conducted by Dr. Maria Hordinsky at the University of Minnesota Department of Dermatology. For additional information, please call the study coordinator: 612-625-2624 or email: [email protected]

 

Androgenetic Alopecia

Hidradenitis Suppurativa

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Hidradenitis Suppurativa

Study Title: Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

We are conducting a research study on individuals with a diagnosis of Hidradenitis Suppurativa. The purpose of this research study is to learn more about the safety and effectiveness of an oral investigational drug called Capsule Microbiota Transplant Therapy. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Participant requirements:

  • Men and women 18 years of age and older
  • Diagnosis of Hidradenitis Suppurativa by a dermatologist
  • Stable doses of all medications 30 days prior to baseline
  • Attend 6 in-person visits over 90 days
  • Comply to phone call follow-ups throughout the study
  • Other requirements, which the study team will review with you

This study is being conducted by Dr. Noah Goldfarb at the University of Minnesota Department of Dermatology. For additional information, please contact the study coordinator: 612-626-0249 or [email protected]

Lupus Erythematosus