PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Psoriasis is a common, long-term health problem that affects more than 8 million Americans. People with psoriasis have painful, thick, red patches on their skin that may itch and bleed. Psoriasis can decrease patients’ quality of life. In some cases, it can also increase the risk of heart attack and stroke. Treatments are available, but not all patients get the treatment they need. African Americans are more likely to have severe psoriasis compared with whites, but they are also less likely to receive effective treatment.
Medicine and phototherapy are two types of psoriasis treatments. Phototherapy, or light therapy, uses ultraviolet light to treat the skin. Many patients prefer phototherapy because medicines can have serious side effects. But patients must go to a clinic three times a week for 12 weeks to get phototherapy. The time and expense of these clinic visits may be a burden for patients.
In this study, the research team is comparing how well home-based phototherapy and clinic-based phototherapy work to improve psoriasis. The team is also looking at whether treatment causes side effects or whether skin color affects how well the treatment works. The team is looking at three skin colors: light white skin, olive to light brown skin, and dark brown to black skin.
Who can this research help?
Results may help clinicians and patients when considering how to treat psoriasis.
What is the research team doing?
The research team is enrolling 1,050 patients ages 12 and older with psoriasis getting treatment at 20 to 40 sites across the United States. Of these patients, 350 have light white skin, 350 have olive to light brown skin, and 350 have dark brown or black skin. The team is assigning patients by chance to one of two groups. The first group receives phototherapy in a clinic. The second group receives phototherapy with a machine at home.
The research team is looking at patients’ medical records after treatment ends to see how well their skin responded to therapy. The team is also surveying patients about the time and costs of phototherapy and what treatment results and side effects they had. Patients also complete a brief survey on their cell phone every four weeks about their quality of life. The team is comparing these outcomes between the home- and clinic-based groups. In addition, the team is looking to see if the effectiveness of the home- and clinic-based treatments varies by the color of patients’ skin.
Patients, the National Psoriasis Foundation, and dermatologists are helping plan and conduct the study.
Research methods at a glance
|Design||Randomized controlled trial|
|Population||1,050 people ages 12 and older with plaque or guttate psoriasis who are candidates for phototherapy|
Primary: treatment response, impact of dermatological disease on quality of life
Secondary: body surface area affected by psoriasis, concomitant topical psoriasis treatment, time traveling for phototherapy appointments, costs associated with traveling for phototherapy appointments, time spent on phototherapy, phototherapy dosing, duration of treatment response
|12-week follow-up for primary outcomes|