The LITE Study is a large pragmatic randomized study to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of plaque or guttate psoriasis. The LITE Study’s pragmatic design differs from a clinical trial in that it will try to reflect real world practice. Therefore, eligibility criteria for patients into this study are not as restrictive in comparison to clinical trials. Additionally, all data collected for the LITE Study is designed to occur during routine clinical visits and do not require any additional scheduling outside of this.
The study is comparing effectiveness instead of efficacy and the differences are outlined in the table below:
The University of Pennsylvania is serving as the coordinating center for this multi-site investigator initiated study. The LITE Study will enroll a total of 1050 participants at 20-40 sites across the country, stratified by skin type with 350 patients with Skin Type 1 and 2, 350 patients with Skin Type 3 and 4, and 350 patients with Skin Type 5 and 6. Recruitment for the study will begin in 2019 and continue over a 3-year period. clinicaltrials.gov
The LITE study is the result of a long standing collaboration between Dr. Joel Gelfand, from the University of Pennsylvania, and Dr. Kristina Callis Duffin, from the University of Utah (Co-PI), and the National Psoriasis Foundation (NPF). The study is funded by the Patient Centered Outcomes Research Institute (PCORI), an independent research institute authorized by Congress in 2010 that funds comparative clinical effectiveness research (CER) that engages patients and other stakeholders throughout the research process. The LITE Study is guided by committee representatives of dermatology experts, patients with psoriasis, and leaders in health care insurance.