A Prospective, Randomized, Intra-patient Investigation to Assess the Clinical Performance and Safety of BIOpH+ Psoriasis Medical Bath for 8 Weeks of Treatment in Subjects With Mild to Moderate Plaque Psoriasis of Affected Body Area.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biocool AB
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8.
研究概览
简要总结
The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device.
详细描述
After being informed about the investigation and the potential risks, all subjects giving written informed consent will undergo screening to determine eligibility for study entry. At week 0, subjects who meet the eligibility requirements will be randomised in open, intra-patient investigation, treated with BIOpH+ Psoriasis Medical Bath on one side, and comparative treatment on the other side for 8 weeks.
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
- None
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
- •Voluntary agreed to participation and has duly signed Informed Consent Form
- •Males and females ≥ 18 years of age
- •In the Investigator's opinion, the patient is not likely to become pregnant during study participation (e.g. in a same-sex relationship, not sexually active, sterile, not of child-bearing age, uses contraception, etc.)
- •Subject diagnosed with stable mild-moderate plaque psoriasis, defined by PASI ≤ 9
- •Intra-individual difference between left and right hemi-body PASI scores not > 1.0
- •Patients with symmetrical psoriasis
排除标准
- •Presence of other forms of psoriasis other than psoriasis vulgaris (palmoplantar psoriasis, inverse psoriasis, other forms of hyperkeratosis)
- •Use of systemic/biological treatment for psoriasis
- •Known hypersensitivity or allergy to study products
- •Any serious medical condition that could interfere with the evaluation of study results
- •Poor compliance in other investigational study, as assessed by investigator
- •Pregnant, breastfeeding, or planning to become pregnant during study
- •Patients with alcohol -or drug abuse
- •Any other conditions as judged by the investigator may make the follow-up or investigation inappropriate
- •Anyone unsuitable to participate as subject according to the Declaration of Helsinki
结局指标
主要结局
Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8.
时间窗: Baseline and week 8.
The PASI score is a validated, investigator instrument assessing the severity of psoriasis. The severity is combined with the percentage of affected area.
次要结局
- Psoriasis Area Severity Index (PASI)(Week 2 and week 4)
- Dermatology Life Quality Index (DLQI)(Baseline and week 8.)
- Physician Global Assessment (PGA)(Baseline, week 2, 4, and 8)
- Tolerability assessment(Week 2, 4 and week 8.)
- Usability /satisfaction assessments(Week 8)