A Prospective, Single-arm, Open-label, Post-market Clinical Follow-up Investigation to Verify Performance and Safety of Daxxin Psoriasis Shampoo When Used for Treatment of Moderate Scalp Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- PSSI score reduction at day 42
研究概览
简要总结
The goal of this clinical investigation is to verify the performance and safety of the CE-marked Daxxin Psoriasis Shampoo to treat scalp psoriasis. Forty-one subjects with moderate scalp psoriasis are planned to be recruited at one site in Sweden. Subjects will be asked to use the shampoo between 3 and 7 times a week, as per the instructions for use from the manufacturer, for a period of 6 weeks.
详细描述
Investigational device: Daxxin Psoriasis Shampoo, Basic UDI-DI: 733116220030
Intended use: Daxxin Psoriasis Shampoo is designed to alleviate symptoms related to scalp psoriasis, such as itchiness, redness, flaking, and scratch marks
Overall design:
This is a prospective, single-arm, open-label, post-market clinical follow-up investigation designed to verify performance and safety of Daxxin Psoriasis Shampoo when used by subjects with scalp psoriasis in need of treatment. The outcome will be evaluated and incorporated in the product specific clinical evaluation report (CER) and serve as a base for continuous investigations.
Following approval from the ethical committee (EC), 41 subjects with the diagnosis of moderate scalp psoriasis will be recruited at sites in Sweden. The subjects should only use Daxxin Psoriasis Shampoo and no other shampoo during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female ≥18 years old
- •Clinical diagnosis of moderate scalp psoriasis assessed by Psoriasis Scalp Severity Index (PSSI, moderate = 3-10)
- •At least a score of 1 grade for each symptom erythema, induration and desquamation
- •Subject is willing and able to use Daxxin Psoriasis Shampoo as directed, comply with investigation instructions, and commit to all follow-up visits for the duration of the investigation, as judged by the Investigator
- •Subject agrees to refrain from using other treatments for scalp psoriasis during the clinical investigation
- •Subject is willing and able to provide written informed consent
排除标准
- •Known allergy or sensitivity to any component of the device
- •Use of psoriasis shampoo 2 weeks prior to enrolment
- •Use of other psoriasis scalp treatment i.e., Betnovate that could affect the study result within 4 weeks prior to enrolment
- •Use of systemic and/or biological treatment for psoriasis
- •Subject has a history of psoriasis unresponsive to topical treatments
- •Subject is pregnant, lactating at time of enrolment, or is planning to become pregnant during the study
- •Subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate
- •Subject with alcohol or drug abuse
研究组 & 干预措施
Scalp psoriasis
Subjects with the diagnosis of moderate scalp psoriasis
干预措施: Daxxin Psoriasis Shampoo (Device)
结局指标
主要结局
PSSI score reduction at day 42
时间窗: From Day 0 (enrollment) to Day 42 after enrollment of each subject
Percentage of subjects with reduction of at least 1-grade in the PSSI (Psoriasis Scalp Severity Index) score, at Visit 4 (Day 42) compared to Day 0 (baseline).
次要结局
- Patient Safety(From the enrollment of the first subject to the last visit of the last subject, which is planned to correspond to a 8-month period)
- PSSI score reduction at Days 14 and 28(From Day 0 (enrollment) to Day 28 after enrollment of each subject)
- DLQI(From Day 0 (enrollment) to Day 42 after enrollment of each subject)
- Subject satisfaction(Day 42 after enrollment of each subject)
- Device usability(Day 42 after enrollment of each subject)
- Safety(From the enrollment of the first subject to the last visit of the last subject, which is planned to correspond to a 8-month period)
- Scratch mark grades(From Day 0 (enrollment) to Day 42 after enrollment of each subject)
- Itching(From Day 0 (enrollment) to Day 42 after enrollment of each subject)
- Subject reported symptoms(From Day 0 (enrollment) to Day 42 after enrollment of each subject)