Summary
The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.
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, 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
Conditions
Psoriasis Vulgaris
Intervention
Psorax35, MCT oil
Location
Haukeland Universitetssjukehus
Bergen
Norway
5021
Status
Recruiting
Source
Arctic Nutrition AS
Results (where available)
View Results
Links
Source: http://clinicaltrials.gov/show/NCT03359577
ClinicalTrials.gov processed this data on December 01, 2017
Published on BioPortfolio: 2017-12-04T07:57:04-0500
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Medical and Biotech [MESH] Definitions
Hla-dr7 Antigen
Human immune-response, D-related antigen encoded by the D locus on chromosome 6 and found on lymphoid cells. It is strongly associated with celiac disease and psoriasis vulgaris.
Tretinoin
An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.
Desmoglein 3
A desmosomal cadherin that is an autoantigen in the acquired skin disorder PEMPHIGUS VULGARIS.
Rhizobium Etli
A species of gram-negative bacteria and nitrogen innoculant of PHASEOLUS VULGARIS.