Psoriasis
Conditions
Keywords
Psoriasis
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.
Detailed description
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.
Interventions
DRUGRiboflavin
Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.
OTHERPlacebo
Matching placebo capsule taken daily for 12 weeks.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Achieving 50% or Greater Psoriasis Area and Severity Index (PASI) Reduction | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Achieving PASI 75, 90, 100 Response | 12 weeks | The number of subjects that achieve a PASI 75, 90, 100 response with intervention as compared to placebo. |
| Subjects Achieving Physician Global Assessment (PGA) Score 0/1 | 12 weeks | 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. |
| Subjects Reporting Pruritus Score 0/1 | 12 weeks | 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. |
| Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1 | 12 weeks | 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. |
| Difference in Riboflavin Serum Plasma Levels and Flavin-adenine Dinucleotide (FAD) | 12 weeks | The difference in serum plasma levels of riboflavin and FAD in subjects treated with intervention as compared to placebo. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Because this is a crossover study, all Participants' data is combined. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Assignment | Withdrawal by Subject | 3 | 2 |
| Second Assignment | Withdrawal by Subject | 0 | 2 |
| Washout | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized 22 - 29 Years of Age | 1 Participants |
| Age, Customized 30 - 39 Years of Age | 0 Participants |
| Age, Customized 40 - 49 Years of Age | 8 Participants |
| Age, Customized 50 - 59 Years of Age | 8 Participants |
| Age, Customized 60 - 69 Years of Age | 5 Participants |
| Age, Customized 70 - 79 Years of Age | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Psoriasis Area and Severity Index (PASI) at Baseline | 8.7 score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 9 / 17 | 7 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riboflavin | Subjects Achieving 50% or Greater Psoriasis Area and Severity Index (PASI) Reduction | 2 Participants |
| Placebo | Subjects Achieving 50% or Greater Psoriasis Area and Severity Index (PASI) Reduction | 2 Participants |
Secondary
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
Population: Not available as assays were not able to be conducted.
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Riboflavin | Subjects Achieving PASI 75, 90, 100 Response | PASI 75 | 0 Participants |
| Riboflavin | Subjects Achieving PASI 75, 90, 100 Response | PASI 90 | 0 Participants |
| Riboflavin | Subjects Achieving PASI 75, 90, 100 Response | PASI 100 | 0 Participants |
| Placebo | Subjects Achieving PASI 75, 90, 100 Response | PASI 75 | 0 Participants |
| Placebo | Subjects Achieving PASI 75, 90, 100 Response | PASI 90 | 0 Participants |
| Placebo | Subjects Achieving PASI 75, 90, 100 Response | PASI 100 | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riboflavin | Subjects Achieving Physician Global Assessment (PGA) Score 0/1 | 2 Participants |
| Placebo | Subjects Achieving Physician Global Assessment (PGA) Score 0/1 | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riboflavin | Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1 | 2 Participants |
| Placebo | Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1 | 3 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riboflavin | Subjects Reporting Pruritus Score 0/1 | 0 Participants |
| Placebo | Subjects Reporting Pruritus Score 0/1 | 2 Participants |