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Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis

This study is currently recruiting participants.
Verified November 2017 by Arctic Nutrition AS
Sponsor:
ClinicalTrials.gov Identifier:
NCT03359577
First Posted: December 1, 2017
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Bergen
Haukeland University Hospital
Information provided by (Responsible Party):
Arctic Nutrition AS
  Purpose
The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.

Condition Intervention
Psoriasis Vulgaris Dietary Supplement: Psorax35 Dietary Supplement: MCT oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate Efficacy of Psorax35 for Treatment of Psoriasis

Resource links provided by NLM:


Further study details as provided by Arctic Nutrition AS:

Primary Outcome Measures:
  • Change in PASI [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 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 [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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) [ Time Frame: Baseline to 32 weeks ]
    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) [ Time Frame: Baseline to 32 weeks ]
    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) [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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) [ Time Frame: Baseline to week 32 ]
    Monitoring of AEs and SAEs.

  • Changes in fasting serum lipids [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    Changes from baseline in serum HbA1c (%) in the Psorax35 group as compared to Placebo at week 12, and 32.

  • Changes in blood pressure [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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) [ Time Frame: Baseline to 32 weeks ]

    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 [ Time Frame: Baseline to 32 weeks ]

    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 [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]
    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 [ Time Frame: Baseline to 32 weeks ]

    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 [ Time Frame: Baseline to 32 weeks ]
    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).


Estimated Enrollment: 60
Actual Study Start Date: November 21, 2017
Estimated Study Completion Date: August 31, 2018
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psorax35
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
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.
Placebo Comparator: MCT oil
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359577


Contacts
Contact: Kåre S Tveit, MD,PhD +47 98664474 kare.steinar.tveit@helse-bergen.no
Contact: Bodil Bjørndal, PhD +47 92027950 Bodil.Bjorndal@uib.no

Locations
Norway
Haukeland Universitetssjukehus Recruiting
Bergen, Norway, 5021
Contact: Kåre S Tveit, MD PhD    +4798664474    kare.steinar.tveit@helse-bergen.no   
Contact: Bodil Bjørndal, PhD    +4792027950    Bodil.Bjorndal@uib.no   
Sponsors and Collaborators
Arctic Nutrition AS
University of Bergen
Haukeland University Hospital
Investigators
Principal Investigator: Rolf Berge, PhD University of Bergen
  More Information

Responsible Party: Arctic Nutrition AS
ClinicalTrials.gov Identifier: NCT03359577     History of Changes
Other Study ID Numbers: Psorax35-H17
First Submitted: November 15, 2017
First Posted: December 1, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arctic Nutrition AS:
Chronic plaque psoriasis
Inflammation
Cardiovascular diseases

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases