- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02622386
The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Riboflavin then Placebo
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.
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Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.
Other Names:
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Placebo Comparator: Placebo then Riboflavin
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.
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Matching placebo capsule taken daily for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects Achieving 50% or Greater Psoriasis Area and Severity Index (PASI) Reduction
Time Frame: 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. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects Achieving PASI 75, 90, 100 Response
Time Frame: 12 weeks
|
The number of subjects that achieve a PASI 75, 90, 100 response with intervention as compared to placebo.
|
12 weeks
|
Subjects Achieving Physician Global Assessment (PGA) Score 0/1
Time Frame: 12 weeks
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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.
|
12 weeks
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Subjects Reporting Pruritus Score 0/1
Time Frame: 12 weeks
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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.
|
12 weeks
|
Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1
Time Frame: 12 weeks
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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. |
12 weeks
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Difference in Riboflavin Serum Plasma Levels and Flavin-adenine Dinucleotide (FAD)
Time Frame: 12 weeks
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The difference in serum plasma levels of riboflavin and FAD in subjects treated with intervention as compared to placebo.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johann Gudjonsson, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00105691 /Derm 677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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