Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis

NCT03359577 | Completed

• 1 other identifier: Psorax35-H17
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Keywords

Chronic plaque psoriasis; Inflammation; Cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• Change in PASI

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

  Baseline to 32 weeks

Secondary Outcomes (22)

• Change in PASI over 24 weeks

  Baseline to 24 weeks

• Number of patients achieving PASI<3

  Baseline to 32 weeks

• Improvement in PASI

  Baseline to 32 weeks

• Change in Physician's Static Global Assessment (PSGA)

  Baseline to 32 weeks

• Change in Dermatology Life Quality Index (DLQI)

  Baseline to 32 weeks

Study Arms (2)

Psorax35

EXPERIMENTAL

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

MCT oil

PLACEBO COMPARATOR

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

Interventions

Psorax35 DIETARY_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.

Psorax35

MCT oil DIETARY_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 oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arctic Nutrition AS: lead
• University of Bergen: collaborator
• Haukeland University Hospital: collaborator

Study Sites (1)

Haukeland Universitetssjukehus

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 32378724 DERIVED

MeSH Terms

Conditions

Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolf Berge, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 2, 2017
• Study Start: November 21, 2017
• Primary Completion: August 24, 2018
• Study Completion: April 29, 2019
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)