PsoriasisPhase 2NCT02622386
The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis
A Phase 2 study testing Riboflavin in people with Psoriasis, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Riboflavin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2016to 6 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Riboflavin, Placebo
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDrug
Also called Vitamin B2
Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.
PlaceboOther
Matching placebo capsule taken daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start11 Aug 2016
- Primary completion6 Apr 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johann E Gudjonsson MD PhD, University of Michigan
- Investigators
- Johann Gudjonsson, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622386
- Sponsor's protocol ID
- HUM00105691 /Derm 677
- Status last verified
- Jul 2022
- First submitted
- 2 Dec 2015
- Last updated
- 28 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis
- ClinicalTrials.gov ID
- NCT02622386
- Acronym / sponsor ID
- HUM00105691 /Derm 677
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Posted 28 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riboflavin then Placebo | Experimental | Drug: RiboflavinRiboflavin (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. |
| Placebo then Riboflavin | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiboflavinAlso: Vitamin B2Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks. | Drug | Riboflavin then Placebo |
| PlaceboMatching placebo capsule taken daily for 12 weeks. | Other | Placebo then Riboflavin |
Primary outcome
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.
5 secondary outcomes
Subjects Achieving PASI 75, 90, 100 Response
Time frame: 12 weeks
Subjects Achieving Physician Global Assessment (PGA) Score 0/1
Time frame: 12 weeks
Subjects Reporting Pruritus Score 0/1
Time frame: 12 weeks
Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1
Time frame: 12 weeks
Difference in Riboflavin Serum Plasma Levels and Flavin-adenine Dinucleotide (FAD)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Gudjonsson, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riboflavin in people with Psoriasis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects Achieving 50% or Greater Psoriasis Area and Severity Index (PASI) Reduction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.