Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Performance measured by reduction of disease severity and symptoms
研究概览
简要总结
The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.
详细描述
The study hypothesis is to demonstrate that 047 TD Dermatitis cream creating a protective layer, on the area where it is applied, which defends the skin from external environmental factors.
The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyze the data needed to study the relationships between different variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/ female > 6 months < 65 years
- •Patient diagnosed AD/CD
- •Patient with EASI max <16
- •Patient with IGA 1-3
- •Patient in good condition with no serious systemic disease
排除标准
- •Hypersensitivity to any 047_TD Dermatitis cream ingredients
- •Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
- •Any other adjuvant therapy for AD/CD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
- •Any use of another topical emollient or other established treatment for AD/CD during the study at the site of flares (AD/CD lesions). Exception are usual hygienic products in the diaper area
- •A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
- •Drug abuser
- •Don't accept to attend the study procedures and processes as outlined in the protocol. Parents don't accept for the subject less 18th years old
- •Could not provide written informed consent or parents' informed consent to have their child participate in the study
结局指标
主要结局
Performance measured by reduction of disease severity and symptoms
时间窗: End of treatment - 28 days.
The evaluation and confirmation of the performance of 047_TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, through a reduction in disease severity and symptoms at 28 days of treatment, will be assessed by Investigator's Global Assessment (IGA) scores (successful threshold established as reduction of 1 point of the IGA score with respect to baseline value).
次要结局
- Performance measured by reduction of disease severity and symptoms at 14 days(14 days of treatment)
- Long lasting itch relief measured by patient reported assessment(Treatment day 14 and 28)
- Eczema improvement assessed by Eczema Area and Severity Index (EASI) score(Treatment day 14 and treatment day 28)
- Anti-itch effect measured by patient reported assessment(Day 1 of treatment)
- Pruritus improvement assessed by VAS(Treatment day 14 and treatment day 28)
- Performance measured by improvement in the Quality of Life(Treatment day 1, 14 and 28)
- Subject adherence to treatment(From enrollment to the end of study on day 28)
- Product usability(From enrollment to the end of study on day 28)
- Overall performance of the device(From enrollment to the end of study on day 28)
- MD Safety evaluation(From enrollment to the end of study on day 28)