The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Riboflavin; Placebo
Intervention description: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.; Matching placebo capsule taken daily for 12 weeks.
Intervention MeSH terms: Riboflavin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Psoriasis

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Good general health

          -  Willingness and ability to follow the protocol

          -  Signed Informed Consent Form, written and witnessed.

          -  Stable moderate to severe chronic plaque psoriasis involving 8% or greater total body
             surface area (TBSA).

          -  If subject is a woman of childbearing potential, she must have a negative pregnancy
             test at screening and agree to use a medically acceptable form of contraception during
             the screening and throughout the study.

        Exclusion Criteria:

          -  Started using a topical steroid stronger than moderate strength, vitamin A or D analog
             preparations, or anthralin within 14 days of study drug initiation.

          -  Initiated a systemic medications, including biologic medication, or phototherapy
             within 180 days of study drug initiation.

          -  Prior or concurrent use of cyclophosphamide.

          -  Currently using sulfasalazine therapy.

          -  Known hypersensitivity to riboflavin.

          -  Enrolled in any other investigational device or investigational drug trial(s) or
             receipt of any other investigational agent(s) within 28 days of baseline visit.

          -  Presence of severe comorbidities such as, diabetes mellitus requiring insulin;
             congestive heart failure (CHF) of any severity or myocardial infarction or
             cerebrovascular accident or transient ischemic attack within 3 months of screening
             visit; unstable angina pectoris, uncontrolled hypertension [sitting systolic BP <80 mm
             Hg or > 160 or diastolic BP > 100 mm Hg], oxygen-dependent severe pulmonary disease,
             history of cancer within 5 years [other than resected cutaneous basal or squamous cell
             carcinoma of the skin or in situ cervical cancer].

          -  Any of the following hematologic abnormalities, confirmed by repeat test at least 1
             week apart:

               1. White blood count <3,000/µL or >14,000/µL

               2. Lymphocyte count <1,000/µL

               3. Neutrophil count <1,5000/µL

               4. Platelet count <150,000/µL

               5. Hemoglobin<10 g/dL

          -  Liver function test aspartate aminotransferase (AST), alanine aminotransferase (ALT)
             or alkaline phosphatase (AlkP) results that are greater than or equal to 2 times the
             upper limit of normal (ULN).

          -  Serum creatinine ≥ to 2x the ULN.

          -  Known HIV-positive status or known history of any other immune-suppressing disease.

          -  Any current or past history of psychiatric disease that would interfere with ability
             to comply with study protocol or give informed consent.

          -  Had grade 3 or 4 adverse events or infections within 28 days before screening, or
             between screening visit and drug initiation.

          -  Evidence of any skin conditions other than psoriasis that would interfere with the
             evaluations of the effect of study medication on psoriasis.

          -  Presence of any condition or circumstances judged by the patient's physician, the
             investigator, or medically qualified study staff to render this clinical trial
             detrimental or otherwise unsuitable for the patient's participation.

          -  A history of non-compliance with other therapies.

          -  Females who are pregnant, lactating, planning on pregnancy during the study period, or
             unwilling to use FDA-approved method of birth control.

          -  A history of keloids or excessive scar formation or of healing poorly.

          -  A history of allergic reaction to local anesthetics, including lidocaine and
             epinephrine