Status:
COMPLETED
Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis
Lead Sponsor:
Arctic Nutrition AS
Collaborating Sponsors:
University of Bergen
Haukeland University Hospital
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
NA
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, p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2019
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03359577
Start Date
November 21 2017
End Date
April 29 2019
Last Update
September 24 2020
Active Locations (1)
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1
Haukeland Universitetssjukehus
Bergen, Norway, 5021