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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.
Matching placebo capsule taken daily for 12 weeks.
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States
Subjects Achieving 50% or Greater Psoriasis Area and Severity Index (PASI) Reduction
The number of subjects that achieve a 50 percent or greater reduction in their PASI with intervention as compared to placebo. The range of absolute PASI scores is 0-72, with higher scores indicating a greater severity of psoriasis. 0 to \<5=Mild psoriasis; 5 to \<10 = Moderate psoriasis; 10 to \<72 = Severe psoriasis.
Time frame: 12 weeks
Subjects Achieving PASI 75, 90, 100 Response
The number of subjects that achieve a PASI 75, 90, 100 response with intervention as compared to placebo.
Time frame: 12 weeks
Subjects Achieving Physician Global Assessment (PGA) Score 0/1
The number of subjects that achieve a PGA score of 0/1 with intervention as compared to placebo. The Global Assessment Scale is a simple instrument with a 9 point ordinal scoring system ranging from -4 indicating very marked worsening to +4 very marked improvement. This scale provides a subjective overall evaluation of treatment response by the patients/caregivers or physicians/health care providers.
Time frame: 12 weeks
Subjects Reporting Pruritus Score 0/1
The number of subjects that report a pruritus score of 0/1 with intervention as compared to placebo. The pruritis scores can range from 0 to 10; where 0 means no itching and 10 means the worst itching.
Time frame: 12 weeks
Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1
The number of subjects treated that report a DLQI score of 0/1 with intervention as compared to placebo. Minimum score 0, maximum score of 30, where 0 means dermatological problems are not causing impairment on their quality of life and 30 means extreme negative impact of dermatological conditions. 0-1 = no effect at all on patient's life; 2-5 = small effect on patient's life; 6-10 = moderate effect on patient's life; 11-20 = very large effect on patient's life; 21-30 = extremely large effect on patient's life.
Time frame: 12 weeks
Difference in Riboflavin Serum Plasma Levels and Flavin-adenine Dinucleotide (FAD)
The difference in serum plasma levels of riboflavin and FAD in subjects treated with intervention as compared to placebo.
Time frame: 12 weeks
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