Trial Outcomes & Findings for The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis (NCT NCT02622386)

Last Updated: 2022-07-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	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 no longer received Riboflavin but matching placebo capsule for additional 12 weeks. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo Then Riboflavin Placebo oral capsule taken once daily for 12 weeks, followed by 4 week washout period before crossover. At crossover, patients no longer received placebo but 400 mg Riboflavin (Vitamin B2) capsule for additional 12 weeks. Placebo: Matching placebo capsule taken daily for 12 weeks.
First Assignment STARTED	12	11
First Assignment COMPLETED	9	9
First Assignment NOT COMPLETED	3	2
Washout STARTED	9	9
Washout COMPLETED	5	5
Washout NOT COMPLETED	4	4
Second Assignment STARTED	5	5
Second Assignment COMPLETED	5	3
Second Assignment NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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 no longer received Riboflavin but matching placebo capsule for additional 12 weeks. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo Then Riboflavin Placebo oral capsule taken once daily for 12 weeks, followed by 4 week washout period before crossover. At crossover, patients no longer received placebo but 400 mg Riboflavin (Vitamin B2) capsule for additional 12 weeks. Placebo: Matching placebo capsule taken daily for 12 weeks.
First Assignment Withdrawal by Subject	3	2
Washout Withdrawal by Subject	4	4
Second Assignment Withdrawal by Subject	0	2

Baseline Characteristics

The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=23 Participants Because this is a crossover study, all Participants' data is combined.
Age, Customized 22 - 29 Years of Age	1 Participants n=5 Participants
Age, Customized 30 - 39 Years of Age	0 Participants n=5 Participants
Age, Customized 40 - 49 Years of Age	8 Participants n=5 Participants
Age, Customized 50 - 59 Years of Age	8 Participants n=5 Participants
Age, Customized 60 - 69 Years of Age	5 Participants n=5 Participants
Age, Customized 70 - 79 Years of Age	1 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants
Psoriasis Area and Severity Index (PASI) at Baseline	8.7 score on a scale n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Riboflavin n=17 Participants Riboflavin (Vitamin B2) 400 mg oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo n=16 Participants Placebo oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Placebo: Matching placebo capsule taken daily for 12 weeks.
Subjects Achieving 50% or Greater Psoriasis Area and Severity Index (PASI) Reduction	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 weeks

The number of subjects that achieve a PASI 75, 90, 100 response with intervention as compared to placebo.

Outcome measures

Outcome measures
Measure	Riboflavin n=17 Participants Riboflavin (Vitamin B2) 400 mg oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo n=16 Participants Placebo oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Placebo: Matching placebo capsule taken daily for 12 weeks.
Subjects Achieving PASI 75, 90, 100 Response PASI 75	0 Participants	0 Participants
Subjects Achieving PASI 75, 90, 100 Response PASI 90	0 Participants	0 Participants
Subjects Achieving PASI 75, 90, 100 Response PASI 100	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Riboflavin n=17 Participants Riboflavin (Vitamin B2) 400 mg oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo n=16 Participants Placebo oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Placebo: Matching placebo capsule taken daily for 12 weeks.
Subjects Achieving Physician Global Assessment (PGA) Score 0/1	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Riboflavin n=17 Participants Riboflavin (Vitamin B2) 400 mg oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo n=16 Participants Placebo oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Placebo: Matching placebo capsule taken daily for 12 weeks.
Subjects Reporting Pruritus Score 0/1	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Riboflavin n=17 Participants Riboflavin (Vitamin B2) 400 mg oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo n=16 Participants Placebo oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Placebo: Matching placebo capsule taken daily for 12 weeks.
Subjects Reporting Dermatology Life Quality Index (DLQI) Score 0/1	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Not available as assays were not able to be conducted.

The difference in serum plasma levels of riboflavin and FAD in subjects treated with intervention as compared to placebo.

Outcome measures

Outcome data not reported

Adverse Events

Riboflavin

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Johann Gudjonsson

University of Michigan

Phone: (734) 615-4508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Riboflavin n=17 participants at risk Riboflavin (Vitamin B2) 400 mg oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Riboflavin: Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.	Placebo n=16 participants at risk Placebo oral capsule taken once daily for 12 weeks either before or after a 4-week washout period. Placebo: Matching placebo capsule taken daily for 12 weeks.
Infections and infestations sinus infection	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Gastrointestinal disorders acid reflux flare	0.00% 0/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Hepatobiliary disorders elevated liver enzymes	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Cardiac disorders elevated blood pressure	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
General disorders fatigue	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Skin and subcutaneous tissue disorders worsening psoriasis	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Skin and subcutaneous tissue disorders folliculitis	0.00% 0/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Respiratory, thoracic and mediastinal disorders nasal congestion	0.00% 0/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
General disorders biopsy reaction	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Nervous system disorders migraine aura	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Surgical and medical procedures abdominal plasty	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
General disorders allergies	0.00% 0/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	12.5% 2/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Infections and infestations cold	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Infections and infestations 24 hour Gastrointestinal event	0.00% 0/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Infections and infestations upper respiratory infection	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Eye disorders eye itching	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Gastrointestinal disorders diarrhea	0.00% 0/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	6.2% 1/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)
Infections and infestations flu	5.9% 1/17 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)	0.00% 0/16 • Participants were followed for 32 weeks (12 weeks of treatment 1; 4 weeks of washout; 12 weeks of treatment 2; and 4 weeks of followup)