Back to resultsClinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psorax35
MCT oil
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Chronic plaque psoriasis, Inflammation, Cardiovascular diseases
Eligibility Criteria
Inclusion Criteria:
- Female and male subjects at least 18 years old understanding Norwegian oral and written information
Diagnosis of mild to moderate psoriasis vulgaris for at least 6 months prior to mild to moderate Psoriasis vulgaris as defined at screening by:
- PASI scores less than 10 (mild psoriasis) and
- Body surface area affected by chronic plaque psoriasis 1%-9.9% (mild and moderate psoriasis)
- Women of childbearing potential must have a negative serum pregnancy test at the screening visit.
Exclusion Criteria:
- Pregnancy
- Initiation of a drug known to cause or exacerbate psoriasis
- Having received an investigational medical product (IMP) or investigational device within 28 days' prior randomization
- Alcohol and drug abuse or any condition associated with poor compliance
- Malabsorption disorder
- Scheduled hospitalization during the course of the study that could compromise the study
- Major diseases or infections
- Known or suspected sensitivity or allergic reactions to the IMP or excipients
- Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk
- Planned trip abroad to a sunny resort involving active sun exposure
- Any anti psoriatic treatment
- Immunosuppressive - immunomodulating treatment given for any other reason than psoriasis
- UV treatment and return from a sunny resort involving active sun exposure for the last 4-6 weeks
Sites / Locations
- Haukeland Universitetssjukehus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Psorax35
MCT oil
Arm Description
Food supplement Psorax35 capsules containing fish roe extract high in eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) phospholipid. Dose: 10 capsules of 590 mg. Route of administration: oral.
Placebo capsules containing coconut oil high in caprylic acid C8:0 and capric acid C10:0 (Medium Chain triglycerides (MCT) oil). Dose: 10 capsules of 590 mg: Route of administration: oral.
Outcomes
Primary Outcome Measures
Change in PASI
Change from baseline in PASI in the Psorax35 group as compared to Placebo at week 32.
Secondary Outcome Measures
Change in PASI over 24 weeks
Change from baseline in PASI in the Psorax35 group as compared to Placebo at week 6, 12, 18, and 24.
Number of patients achieving PASI<3
Number of patients achieving PASI<3 in the Psorax35 group as compared to Placebo at week 6, 12, 18, 24, and 32.
Improvement in PASI
Difference in 50% improvement in PASI (PASI-50), difference in 75% improvement in PASI (PASI-75) and difference in 90% improvement in PASI (PASI-90) from baseline in the Psorax35 group as compared with Placebo group at week 6, 12, 18, 24, and 32.
Change in Physician's Static Global Assessment (PSGA)
Changes from baseline in PSGA=0-1 demonstrating clear or almost clear skin in the Psorax35 group as compared to Placebo group at week 6, 12, 18, 24, and 32.
Change in Dermatology Life Quality Index (DLQI)
Changes from baseline in DLQ index in the Psorax35 group as compared to Placebo at week 6, 12, 18, 24, and 32.
Change in EuroQoL 5 index (EQ-5D)
Change from baseline in EuroQoL 5 index in the Psorax35 group as compared to Placebo group at week 6, 12, 18, 24, and 32.
Change in Visual analogue scale (VAS) score
Changes from baseline in VAS Scores (pruritus, pain skin/joints, stinging and total health condition (general/skin)) in the Psorax35 group as compared to Placebo at week 6, 12, 18, 24, and 32.
Changes in highly sensitive C-reactive protein
Changes from baseline in highly sensitive C-reactive protein (mg/L) in the Psorax35 group as compared to Placebo at week 12, and 32.
Adverse Events (AE) and Severe Adverse Events (SAE)
Monitoring of AEs and SAEs.
Changes in fasting serum lipids
Changes from baseline in serum lipids (Triacylglycerol (TAG), total cholesterol (TK), HDL-cholesterol, LDL-cholesterol, free-cholesterol, phospholipids, non-esterified fatty acids, non-HDL-cholesterol - mmol/L) and lipid ratios (TAG/TK ratio, HDL-chol/LDL-chol ratio), in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Changes in fasting serum glucose
Changes from baseline in serum glucose (mmol/L) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32
Changes in fasting serum insulin and insulin C-peptide
Changes from baseline in serum insulin (mIE/L) and insulin C-peptide (nmol/L) in the Psorax35 group as compared to Placebo at week 12, and 32.
Changes in fasting serum HbA1c
Changes from baseline in serum HbA1c (%) in the Psorax35 group as compared to Placebo at week 12, and 32.
Changes in blood pressure
Changes from baseline in blood pressure (mmHg) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Changes in heart rate
Changes from baseline in heart rate (bpm) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Changes in Body Mass Index (BMI)
Changes from baseline in Body Mass Index (BMI) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Weight in kilograms and height in meters will be combined to report BMI in kg/m2
Changes in waist/hip ratio
Changes from baseline in waist/hip ratio in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Waist in centimeters and hip in centimeters will be combined to report waist/hip ratio.
Changes in plasma cytokines including adipocytokines
Changes from baseline in plasma cytokines including adipocytokines (pg/mL) in the Psorax35 group as compared to Placebo group at week 12, and 32.
Changes in serum antioxidant capacity
Changes from baseline in serum antioxidant capacity (nmol Trolox ekv./ul) in the Psorax35 group as compared to Placebo group at week 12, and 32.
Changes in serum Vitamin D
Changes from baseline in serum Vitamin D (nmol/L) in the psorax35 group as compared to Placebo group at week 12, and 32.
Difference in use of cream-based treatment
Difference in use of rescue medication from baseline in the Psorax35 group as compared to placebo group at week 6, 12, 18, 24, and 32.
Amount of cream-based treatment in grams and number of days treated will be combined to report the use.
Changes in safety laboratory parameters including hematology, clinical chemistry
Changes from baseline in safety laboratory parameters including hematology (Hemoglobin-g/dL, Hematocrit, Erythrocytes-10^9/L, Leukocytes-10^9/L, Lymphocytes-10^9/L, Monocytes-10^9/L, Eosinophiles-10^9/L, Neutrophiles-10^9/L, Blood plates-10^9/L), and clinical chemistry (ALAT-u/L, lactate dehydrogenase-u/L, creatine kinase-u/L, creatinine-umol/L, gamma-glutamyltransferase-u/L).
Full Information
NCT ID
NCT03359577
First Posted
November 15, 2017
Last Updated
September 23, 2020
Sponsor
Arctic Nutrition AS
Collaborators
University of Bergen, Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03359577
Brief Title
Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis
Official Title
Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate Efficacy of Psorax35 for Treatment of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
August 24, 2018 (Actual)
Study Completion Date
April 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arctic Nutrition AS
Collaborators
University of Bergen, Haukeland University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.
Detailed Description
Psoriasis is a common, genetically predisposed, inflammatory and proliferative disease of the skin, the most characteristic lesions consisting of chronic, sharply demarcated, dull-red scaly plaques, particularly on extensor parts of limbs and in the scalp. Psoriasis can be divided into mild, moderate or severe psoriasis based on the extent of the skin changes
Psorax35, which is extracted from herring roe are shown to improve the condition of people with psoriasis.
The objective of this study is to investigate the effect, safety, and mechanism of action of Psorax35 on mild to moderate Psoriasis and comorbidities associated with psoriasis through a 32-weeks study.
The participants will be randomized into one of two arms; Psorax35 and Placebo. The study will include a total of 6 treatment visits involving Blood samples, Photo documentation, Psoriasis and Severity index (PASI), Body surface area (BSA), Physician's Static Global Assessment (PSGA), Life quality index (EQ-5D, VAS and DLQI), Blood pressure, Blood rate, Body Mass Index (BMI), Waist circumference, Waist/hip ratio, and 24 hrs dietary recall. At visit 4 Blood samples, Blood pressure, Blood rate, BMI, Waist circumference, Waist/hip ratio, and 24 hrs dietary recall are not included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Chronic plaque psoriasis, Inflammation, Cardiovascular diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psorax35
Arm Type
Experimental
Arm Description
Food supplement Psorax35 capsules containing fish roe extract high in eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) phospholipid. Dose: 10 capsules of 590 mg. Route of administration: oral.
Arm Title
MCT oil
Arm Type
Placebo Comparator
Arm Description
Placebo capsules containing coconut oil high in caprylic acid C8:0 and capric acid C10:0 (Medium Chain triglycerides (MCT) oil). Dose: 10 capsules of 590 mg: Route of administration: oral.
Intervention Type
Dietary Supplement
Intervention Name(s)
Psorax35
Intervention Description
This is a randomized, 32 weeks, single center, placebo controlled, double blind study to investigate Psorax35 supplementation in patients with mild to moderate Psoriasis. Groups of patients will be block randomized using randomly selected block sizes, and stratified according to gender.
Intervention Type
Dietary Supplement
Intervention Name(s)
MCT oil
Intervention Description
This is a randomized, 32 weeks, single center, placebo controlled, double blind study to investigate Psorax35 supplementation in patients with mild to moderate Psoriasis. Groups of patients will be block randomized using randomly selected block sizes, and stratified according to gender.
Primary Outcome Measure Information:
Title
Change in PASI
Description
Change from baseline in PASI in the Psorax35 group as compared to Placebo at week 32.
Time Frame
Baseline to 32 weeks
Secondary Outcome Measure Information:
Title
Change in PASI over 24 weeks
Description
Change from baseline in PASI in the Psorax35 group as compared to Placebo at week 6, 12, 18, and 24.
Time Frame
Baseline to 24 weeks
Title
Number of patients achieving PASI<3
Description
Number of patients achieving PASI<3 in the Psorax35 group as compared to Placebo at week 6, 12, 18, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Improvement in PASI
Description
Difference in 50% improvement in PASI (PASI-50), difference in 75% improvement in PASI (PASI-75) and difference in 90% improvement in PASI (PASI-90) from baseline in the Psorax35 group as compared with Placebo group at week 6, 12, 18, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Change in Physician's Static Global Assessment (PSGA)
Description
Changes from baseline in PSGA=0-1 demonstrating clear or almost clear skin in the Psorax35 group as compared to Placebo group at week 6, 12, 18, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Change in Dermatology Life Quality Index (DLQI)
Description
Changes from baseline in DLQ index in the Psorax35 group as compared to Placebo at week 6, 12, 18, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Change in EuroQoL 5 index (EQ-5D)
Description
Change from baseline in EuroQoL 5 index in the Psorax35 group as compared to Placebo group at week 6, 12, 18, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Change in Visual analogue scale (VAS) score
Description
Changes from baseline in VAS Scores (pruritus, pain skin/joints, stinging and total health condition (general/skin)) in the Psorax35 group as compared to Placebo at week 6, 12, 18, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in highly sensitive C-reactive protein
Description
Changes from baseline in highly sensitive C-reactive protein (mg/L) in the Psorax35 group as compared to Placebo at week 12, and 32.
Time Frame
Baseline to 32 weeks
Title
Adverse Events (AE) and Severe Adverse Events (SAE)
Description
Monitoring of AEs and SAEs.
Time Frame
Baseline to week 32
Title
Changes in fasting serum lipids
Description
Changes from baseline in serum lipids (Triacylglycerol (TAG), total cholesterol (TK), HDL-cholesterol, LDL-cholesterol, free-cholesterol, phospholipids, non-esterified fatty acids, non-HDL-cholesterol - mmol/L) and lipid ratios (TAG/TK ratio, HDL-chol/LDL-chol ratio), in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in fasting serum glucose
Description
Changes from baseline in serum glucose (mmol/L) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32
Time Frame
Baseline to 32 weeks
Title
Changes in fasting serum insulin and insulin C-peptide
Description
Changes from baseline in serum insulin (mIE/L) and insulin C-peptide (nmol/L) in the Psorax35 group as compared to Placebo at week 12, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in fasting serum HbA1c
Description
Changes from baseline in serum HbA1c (%) in the Psorax35 group as compared to Placebo at week 12, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in blood pressure
Description
Changes from baseline in blood pressure (mmHg) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in heart rate
Description
Changes from baseline in heart rate (bpm) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in Body Mass Index (BMI)
Description
Changes from baseline in Body Mass Index (BMI) in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Weight in kilograms and height in meters will be combined to report BMI in kg/m2
Time Frame
Baseline to 32 weeks
Title
Changes in waist/hip ratio
Description
Changes from baseline in waist/hip ratio in the Psorax35 group as compared to Placebo at week 6, 12, 24, and 32.
Waist in centimeters and hip in centimeters will be combined to report waist/hip ratio.
Time Frame
Baseline to 32 weeks
Title
Changes in plasma cytokines including adipocytokines
Description
Changes from baseline in plasma cytokines including adipocytokines (pg/mL) in the Psorax35 group as compared to Placebo group at week 12, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in serum antioxidant capacity
Description
Changes from baseline in serum antioxidant capacity (nmol Trolox ekv./ul) in the Psorax35 group as compared to Placebo group at week 12, and 32.
Time Frame
Baseline to 32 weeks
Title
Changes in serum Vitamin D
Description
Changes from baseline in serum Vitamin D (nmol/L) in the psorax35 group as compared to Placebo group at week 12, and 32.
Time Frame
Baseline to 32 weeks
Title
Difference in use of cream-based treatment
Description
Difference in use of rescue medication from baseline in the Psorax35 group as compared to placebo group at week 6, 12, 18, 24, and 32.
Amount of cream-based treatment in grams and number of days treated will be combined to report the use.
Time Frame
Baseline to 32 weeks
Title
Changes in safety laboratory parameters including hematology, clinical chemistry
Description
Changes from baseline in safety laboratory parameters including hematology (Hemoglobin-g/dL, Hematocrit, Erythrocytes-10^9/L, Leukocytes-10^9/L, Lymphocytes-10^9/L, Monocytes-10^9/L, Eosinophiles-10^9/L, Neutrophiles-10^9/L, Blood plates-10^9/L), and clinical chemistry (ALAT-u/L, lactate dehydrogenase-u/L, creatine kinase-u/L, creatinine-umol/L, gamma-glutamyltransferase-u/L).
Time Frame
Baseline to 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female and male subjects at least 18 years old understanding Norwegian oral and written information
Diagnosis of mild to moderate psoriasis vulgaris for at least 6 months prior to mild to moderate Psoriasis vulgaris as defined at screening by:
PASI scores less than 10 (mild psoriasis) and
Body surface area affected by chronic plaque psoriasis 1%-9.9% (mild and moderate psoriasis)
Women of childbearing potential must have a negative serum pregnancy test at the screening visit.
Exclusion Criteria:
Pregnancy
Initiation of a drug known to cause or exacerbate psoriasis
Having received an investigational medical product (IMP) or investigational device within 28 days' prior randomization
Alcohol and drug abuse or any condition associated with poor compliance
Malabsorption disorder
Scheduled hospitalization during the course of the study that could compromise the study
Major diseases or infections
Known or suspected sensitivity or allergic reactions to the IMP or excipients
Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk
Planned trip abroad to a sunny resort involving active sun exposure
Any anti psoriatic treatment
Immunosuppressive - immunomodulating treatment given for any other reason than psoriasis
UV treatment and return from a sunny resort involving active sun exposure for the last 4-6 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Berge, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland Universitetssjukehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32378724
Citation
Tveit KS, Brokstad KA, Berge RK, Saebo PC, Hallaraker H, Brekke S, Meland N, Bjorndal B. A Randomized, Double-blind, Placebo-controlled Clinical Study to Investigate the efficacy of Herring Roe Oil for treatment of Psoriasis. Acta Derm Venereol. 2020 May 28;100(10):adv00154. doi: 10.2340/00015555-3507.
Results Reference
derived
Learn more about this trial
Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis
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