Psoriasis VulgarisNCT03359577
Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis
A study testing Psorax35 and MCT oil in people with Psoriasis Vulgaris, run by Arctic Nutrition AS at 1 site in Norway.
Trial summary
The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Psorax35 and MCT oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNorway
- Study dates
- 21 Nov 2017to 29 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate Efficacy of Psorax35 for Treatment of Psoriasis
The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Psorax35, MCT oil
- Keywords
- Chronic plaque psoriasis, Inflammation, Cardiovascular diseases
- Medical subject headings
- Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: MCT oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PASI
Change from baseline in PASI in the Psorax35 group as compared to Placebo at week 32.
Measured: Baseline to 32 weeks
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 32 weeks
Adverse Events (AE) and Severe Adverse Events (SAE)
Monitoring of AEs and SAEs.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start21 Nov 2017
- Primary completion24 Aug 2018
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arctic Nutrition AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bergen, Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Rolf Berge, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359577
- Sponsor's protocol ID
- Psorax35-H17
- Status last verified
- Sep 2020
- First submitted
- 15 Nov 2017
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32378724
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate Efficacy of Psorax35 for Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT03359577
- Acronym / sponsor ID
- Psorax35-H17
- Conditions
- Psoriasis Vulgaris
- Keywords
- Chronic plaque psoriasis, Inflammation, Cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Arctic Nutrition ASIndustry (pharma, biotech, devices)
- Collaborators
- University of Bergen, Haukeland University Hospital
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psorax35 | Experimental | Dietary Supplement: Psorax35Food 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. |
| MCT oil | Placebo comparator | Dietary Supplement: MCT oilPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Women of childbearing potential must have a negative serum pregnancy test at the screening visit.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psorax35This 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. | Dietary supplement | Psorax35 |
| MCT oilThis 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. | Dietary supplement | MCT oil |
Primary outcome
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.
22 secondary outcomes
Change in PASI over 24 weeks
Time frame: Baseline to 24 weeks
Number of patients achieving PASI<3
Time frame: Baseline to 32 weeks
Improvement in PASI
Time frame: Baseline to 32 weeks
Change in Physician's Static Global Assessment (PSGA)
Time frame: Baseline to 32 weeks
Change in Dermatology Life Quality Index (DLQI)
Time frame: Baseline to 32 weeks
Change in EuroQoL 5 index (EQ-5D)
Time frame: Baseline to 32 weeks
Change in Visual analogue scale (VAS) score
Time frame: Baseline to 32 weeks
Changes in highly sensitive C-reactive protein
Time frame: Baseline to 32 weeks
Adverse Events (AE) and Severe Adverse Events (SAE)
Time frame: Baseline to week 32
Changes in fasting serum lipids
Time frame: Baseline to 32 weeks
Changes in fasting serum glucose
Time frame: Baseline to 32 weeks
Changes in fasting serum insulin and insulin C-peptide
Time frame: Baseline to 32 weeks
Changes in fasting serum HbA1c
Time frame: Baseline to 32 weeks
Changes in blood pressure
Time frame: Baseline to 32 weeks
Changes in heart rate
Time frame: Baseline to 32 weeks
Changes in Body Mass Index (BMI)
Time frame: Baseline to 32 weeks
Changes in waist/hip ratio
Time frame: Baseline to 32 weeks
Changes in plasma cytokines including adipocytokines
Time frame: Baseline to 32 weeks
Changes in serum antioxidant capacity
Time frame: Baseline to 32 weeks
Changes in serum Vitamin D
Time frame: Baseline to 32 weeks
Difference in use of cream-based treatment
Time frame: Baseline to 32 weeks
Changes in safety laboratory parameters including hematology, clinical chemistry
Time frame: Baseline to 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Derived from this study: PubMed 32378724Tveit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Berge, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psorax35 and MCT oil in people with Psoriasis Vulgaris, run by Arctic Nutrition AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PASI (time frame: Baseline to 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.