The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis

NCT02622386 | Completed Phase 2 Results

• 1 other identifier: HUM00105691 /Derm 677
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (5)

• Subjects Achieving PASI 75, 90, 100 Response

  12 weeks

• Subjects Achieving Physician Global Assessment (PGA) Score 0/1

  12 weeks

• Subjects Reporting Pruritus Score 0/1

  12 weeks

• Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1

  12 weeks

• Difference in Riboflavin Serum Plasma Levels and Flavin-adenine Dinucleotide (FAD)

  12 weeks

Study Arms (2)

Riboflavin then Placebo

EXPERIMENTAL

Riboflavin (Vitamin B2) 400 mg oral capsule taken once daily for 12 weeks, followed by 4 week washout period before crossover. At crossover, patients will no longer receive Riboflavin but matching placebo capsule for additional 12 weeks.

Drug: Riboflavin

Placebo then Riboflavin

PLACEBO COMPARATOR

Placebo oral capsule taken once daily for 12 weeks, followed by 4 week washout period before crossover. At crossover, patients will no longer receive placebo but 400 mg Riboflavin (Vitamin B2) capsule for additional 12 weeks.

Other: Placebo

Interventions

Riboflavin DRUG

Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.

Also known as: Vitamin B2

Riboflavin then Placebo

Placebo OTHER

Matching placebo capsule taken daily for 12 weeks.

Placebo then Riboflavin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• White blood count \<3,000/µL or \>14,000/µL
• Lymphocyte count \<1,000/µL
• Neutrophil count \<1,5000/µL
• Platelet count \<150,000/µL
• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Johann Gudjonsson
• Organization: University of Michigan

johanng@med.umich.edu

(734) 615-4508

Study Officials

• Johann Gudjonsson, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: August 11, 2016
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: July 28, 2022
• Results First Posted: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)