An interventional study of Psorax35 and MCT oil in Psoriasis Vulgaris, sponsored by Arctic Nutrition AS. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-24.
Sponsored by Arctic Nutrition AS · Not applicable, Interventional, and Treatment
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 64 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →Arctic Nutrition AS is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Inflammation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of mild to moderate psoriasis vulgaris for at least 6 months prior to mild to moderate Psoriasis vulgaris as defined at screening by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Psorax35
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.
Dietary Supplement: MCT oil
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.
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.
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
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.
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
Plan to share: No
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Arctic Nutrition AS