Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis

Arctic Nutrition AS64 enrolled

Overview

The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis Vulgaris

Interventions

Psorax35DIETARY_SUPPLEMENT

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.

MCT oilDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female and male subjects at least 18 years old understanding Norwegian oral and written information 2. 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) 3. Women of childbearing potential must have a negative serum pregnancy test at the screening visit. Exclusion Criteria: 1. Pregnancy 2. Initiation of a drug known to cause or exacerbate psoriasis 3. Having received an investigational medical product (IMP) or investigational device within 28 days' prior randomization 4. Alcohol and drug abuse or any condition associated with poor compliance 5. Malabsorption disorder 6. Scheduled hospitalization during the course of the study that could compromise the study 7. Major diseases or infections 8. Known or suspected sensitivity or allergic reactions to the IMP or excipients 9. 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 10. Planned trip abroad to a sunny resort involving active sun exposure 11. Any anti psoriatic treatment 12. Immunosuppressive - immunomodulating treatment given for any other reason than psoriasis 13. UV treatment and return from a sunny resort involving active sun exposure for the last 4-6 weeks

Locations (1)

Haukeland Universitetssjukehus

Bergen, Norway

Outcomes

Primary Outcomes

Change in PASI

Change from baseline in PASI in the Psorax35 group as compared to Placebo at week 32.

Time frame: Baseline to 32 weeks

Secondary Outcomes

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.

Time frame: Baseline to 24 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Data from ClinicalTrials.gov

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Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

Adverse Events (AE) and Severe Adverse Events (SAE)

Monitoring of AEs and SAEs.

Time frame: Baseline to week 32

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.

Time frame: Baseline to 32 weeks

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

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

Changes in fasting serum HbA1c

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

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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.

Time frame: Baseline to 32 weeks

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).

Time frame: Baseline to 32 weeks