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The purpose of this study is to determine the anti-inflammatory effect of high-dose riboflavin supplementation on chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms. Amongst patients with skin disease, there is significant interest in using complementary alternative medicine and vitamins to treat their disease. Previous human case reports suggest that riboflavin, commonly known as Vitamin B2, is clinically effective for the treatment of psoriasis; however, they were not conclusive. More recent human trials have shown that 400 mg of daily oral riboflavin is a safe and well-tolerated medication to administer to humans. For the purpose of this study, the riboflavin is used as an investigational drug.
The purpose of this investigation is to determine the anti-inflammatory effect of high-dose riboflavin supplementation on chronic plaque psoriasis. Up to fifty volunteers with chronic plaque psoriasis will be recruited for a double-blind, placebo-controlled 28 week prospective study with cross-over of both the intervention and control groups at the 12 week time mark. There will be a 4 week washout period when subjects crossover. Riboflavin will be dosed 400 mg by mouth daily versus placebo. Throughout the study the investigators will perform both clinical and laboratory assessments to measure response.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States
Start Date
August 11, 2016
Primary Completion Date
April 6, 2020
Completion Date
April 6, 2020
Last Updated
July 28, 2022
23
ACTUAL participants
Riboflavin
DRUG
Placebo
OTHER
Lead Sponsor
University of Michigan
NCT07449234
NCT07116967
NCT07250802
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