Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate Efficacy of Psorax35 for Treatment of Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in PASI
研究概览
简要总结
The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Psorax35
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.
干预措施: Psorax35 (Dietary Supplement)
MCT oil
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.
干预措施: MCT oil (Dietary Supplement)
结局指标
主要结局
Change in PASI
时间窗: Baseline to 32 weeks
Change from baseline in PASI in the Psorax35 group as compared to Placebo at week 32.
次要结局
- Number of patients achieving PASI<3(Baseline to 32 weeks)
- Changes in highly sensitive C-reactive protein(Baseline to 32 weeks)
- Change in PASI over 24 weeks(Baseline to 24 weeks)
- Change in Physician's Static Global Assessment (PSGA)(Baseline to 32 weeks)
- Change in Visual analogue scale (VAS) score(Baseline to 32 weeks)
- Changes in fasting serum glucose(Baseline to 32 weeks)
- Improvement in PASI(Baseline to 32 weeks)
- Change in EuroQoL 5 index (EQ-5D)(Baseline to 32 weeks)
- Adverse Events (AE) and Severe Adverse Events (SAE)(Baseline to week 32)
- Changes in fasting serum lipids(Baseline to 32 weeks)
- Changes in fasting serum HbA1c(Baseline to 32 weeks)
- Changes in blood pressure(Baseline to 32 weeks)
- Changes in serum Vitamin D(Baseline to 32 weeks)
- Change in Dermatology Life Quality Index (DLQI)(Baseline to 32 weeks)
- Changes in fasting serum insulin and insulin C-peptide(Baseline to 32 weeks)
- Difference in use of cream-based treatment(Baseline to 32 weeks)
- Changes in safety laboratory parameters including hematology, clinical chemistry(Baseline to 32 weeks)
- Changes in heart rate(Baseline to 32 weeks)
- Changes in waist/hip ratio(Baseline to 32 weeks)
- Changes in serum antioxidant capacity(Baseline to 32 weeks)
- Changes in Body Mass Index (BMI)(Baseline to 32 weeks)
- Changes in plasma cytokines including adipocytokines(Baseline to 32 weeks)