Clinical trial NCT03359577: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Keywords: Chronic plaque psoriasis
Inflammation
Cardiovascular diseases
Lead sponsor: Arctic Nutrition AS
Sponsor class: INDUSTRY
Collaborators: name: University of Bergen
name: Haukeland University Hospital
First posted: 2017-12-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in PASI
timeFrame: Baseline to 32 weeks
Secondary outcomes:
measure: Change in PASI over 24 weeks
timeFrame: Baseline to 24 weeks
measure: Number of patients achieving PASI<3
timeFrame: Baseline to 32 weeks
measure: Improvement in PASI
timeFrame: Baseline to 32 weeks
measure: Change in Physician's Static Global Assessment (PSGA)
timeFrame: Baseline to 32 weeks
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to 32 weeks
measure: Change in EuroQoL 5 index (EQ-5D)
timeFrame: Baseline to 32 weeks
measure: Change in Visual analogue scale (VAS) score
timeFrame: Baseline to 32 weeks
measure: Changes in highly sensitive C-reactive protein
timeFrame: Baseline to 32 weeks
measure: Adverse Events (AE) and Severe Adverse Events (SAE)
timeFrame: Baseline to week 32
measure: Changes in fasting serum lipids
timeFrame: Baseline to 32 weeks
measure: Changes in fasting serum glucose
timeFrame: Baseline to 32 weeks
measure: Changes in fasting serum insulin and insulin C-peptide
timeFrame: Baseline to 32 weeks
measure: Changes in fasting serum HbA1c
timeFrame: Baseline to 32 weeks
measure: Changes in blood pressure
timeFrame: Baseline to 32 weeks
measure: Changes in heart rate
timeFrame: Baseline to 32 weeks
measure: Changes in Body Mass Index (BMI)
timeFrame: Baseline to 32 weeks
measure: Changes in waist/hip ratio
timeFrame: Baseline to 32 weeks
measure: Changes in plasma cytokines including adipocytokines
timeFrame: Baseline to 32 weeks
measure: Changes in serum antioxidant capacity
timeFrame: Baseline to 32 weeks
measure: Changes in serum Vitamin D
timeFrame: Baseline to 32 weeks
measure: Difference in use of cream-based treatment
timeFrame: Baseline to 32 weeks
measure: Changes in safety laboratory parameters including hematology, clinical chemistry
timeFrame: Baseline to 32 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland Universitetssjukehus
Study officials:
affiliation: University of Bergen
name: Rolf Berge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.