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The Department of Dermatology deals with all aspects of the biology and diseases of the skin.

Department of Dermatology
 

Ongoing Clinical Research Studies


The University of Colorado Department of Dermatology has several ongoing clinical research studies. Click on the links below to learn more about the Investigators and their studies. For questions or additional information, please send an e-mail to psoriasiscolorado@ucdenver.edu


Seeking Patients to Participate: (Call 720-848-3607 if you’d like to participate or have questions)

Psoriasis
PI: April W. Armstrong MD, MPH
Study coordinator: Aleksandra Florek 720-848-3607 Email: Aleksandra.Florek@udenver.edu
Title: A Study to Determine the Effect of Psoriasis Treatment on Cardiometabolic Disease
Length of study: 1 year
Approved by COMIRB (Colorado Multiple Institutional Review Board) as study #13-2720
Purpose: The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis.
Main procedures involved: Patients will receive one of three treatments: Humira, NB-UVB phototherapy, or placebo.  FDG-PET/CT will be performed in the beginning as well as at the end of the study in order to evaluate the amount of inflammation.
Eligibility criteria: We are looking for males and females 18 years of age and older with a diagnosis of psoriasis for at least 6 months.
Compensation: Eligible participants will be compensated for participation and may receive FDA-approved study medication, study-related medical care, and study procefures free of charge.

PI: April W. Armstrong, MD, MPH
Study Coordinator: Aleksandra Florek 720-848-3607 Email: Aleksandra.Florek@ucdenver.edu
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis
Length of study: 3 years.
Purpose: VOYAGE1 is a clinical research study that is evaluating safety and effectiveness of a new investigational drug in psoriasis. This study is researching the efficacy and safety of a new biologic [in the final phase of pre-marketing testing] as a treatment for psoriasis.
Main procedures involved: You will be given either Humira, placebo, or the investigational drug for up to 16 weeks, after which you may be switched over to the active drug depending on your response.
Eligibility criteria: You may be eligible to participate if you are 18 years of age or older and have been diagnosed with moderate to severe plaque-type psoriasis for at least 6 months.
Compensation: Study participants will receive study-related procedures and study medication at no cost.

PI: April W. Armstrong, MD, MPH
Study coordinator: Aleksandra Florek 720-848-3607 Email: Aleksandra.Florek@ucdenver.edu
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Sutdy Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis with Randomized Withdrawal and Retreatment
Length of study: 3 years
Approved by COMIRB (Colorado Multiple Institutional Review Board) as study #14-1692
Purpose:  The study will evaluate an investigational drug compared to a currently approve3d psoriasis medication.  Your participation will provide valuable information to researchers seeking new and improved therapies.  VOYAGE2 is a clinical research study that is evaluating safety and effectiveness of a new investigational drug in psoriasis.
Main procedures involved: You will be given either Humira, placebo, or the investigational drug for up to 28 weeks, after which you may be switched over to the active drug depending on your response.
Eligibility criteria: You may be eligible to participate if you are 18 years of age or older and have been diagnosed with moderate to severe plaque-type psoriasis for at least 6 months.
Compensation: Study participants will receive study-related procedures and study medication at no cost.

PI: April W. Armstrong, MD, MPH
Study coordinator: Aleksandra Florek 720-848-3607 Email: Aleksandra.Florek@ucdenver.edu
Title: A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate the efficacy of subcutaneous secukinumab [300mg] as assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 weeks of treatment, compared to placebo, and to assess safety and tolerability up to 24 weeks in adult subjects with moderate to severe scalp psoriasis.
Length of study: 24 weeks.
Purpose: The study assesses the safety and tolerability of the drug secukinumab in patients with moderate to severe scalp psoriasis with or without plaque psoriasis elsewhere on the body.
Main procedures involved: During teh study, you will receive injections of either the actie study drug or placebo, have physical examinations, blood tests, and psoriasis skin assessments.
Eligibility criteria: To qualify for this study, you must be an adult 18 years of age or older, and you must be diagnosed with moderate to severe scalp psoriasis (for at least six months).
Compensation: Participants may be eligible to receive 24 weeks of study drug at no cost.

PI: April W. Armstrong, MD, MPH
Study Coordinator: Aleksandra Florek 720-848-3607  Email: Aleksandra.Florek@ucdenver.edu
Title: Collaborative Connected Health: A pragmatic trial evaluating effectiveness of CCH in psoriasis management compared to in-person visits.
Length of study: 12 months.
Purpose: Study will determine whether seeing a dermatologist online is cost-saving and more efficient compared to in-person visit.
Main procedures involved: Patients will be randomly assigned to one of two groups, "online" care or "face-to-face" care.  If you get randomized to online care, you will not need to travel to a dermatologist and instead you'll upload photos of your skin lesions online.  We will follow patients for 12 months, and compared psoriasis severity, qualty-of-life, and access-to-care measures, and health economics between online care versus in-person care.
Eligibility criteria: In order to qualify for the study, you must be 18 years or older and have psoriasis. You must have access to the internet, and a digital camera or a mobile phone with a camera.
Compensation: Compensation provided.

 

Selected Other Ongoing Psoriasis Studies (no longer recruiting):

Psoriasis
PI: April W. Armstrong MD, MPH
Study coordinator: Aleksandra Florek 720-848-3607 Email: Aleksandra.Florek@ucdenver.edu
Title: A 12-Week Multicenter Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis with a Long-Term Extension Period.
Length of Study: 5 years
Approved by WIRB (Western Institutional Review Board) as study # 20121432 (and as COMIRB #13-2723)

To find out more about dermatology clinical research studies, exactly what they are and how you can participate, click here.

Or contact us at:

Psoriasis Colorado Dermatology Clinical Research Unit
University of Colorado Anschutz Medical Campus
Mail Stop F703
Anschutz Cancer Pavilion
1665 Aurora Court, Room 3234
Aurora, CO 80045
Telephone: (720) 848-3607
Fax: (720) 848-0530
E-mail: psoriasiscolorado@ucdenver.edu