Clinical Trial Finder

Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis

Study Purpose

The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03359577
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Arctic Nutrition AS
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rolf Berge, PhD
Principal Investigator Affiliation University of Bergen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, Other
Overall Status Recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis Vulgaris
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Haukeland Universitetssjukehus, Bergen, Norway

Status

Recruiting

Address

Haukeland Universitetssjukehus

Bergen, , 5021

Site Contact

Kåre S Tveit, MD PhD

kare.steinar.tveit@helse-bergen.no

+4798664474

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.