jRCTs032230006已完成不适用
A Half-Side Comparative Study on Efficacy and Safety of Facial Machine with radio wave and EMS function on Skin of Adult Patients with Atopic Dermatitis
未提供0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- EASI score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 60age old not（—）
- 性别
- All
入选标准
- •Patients who did not use a facial machine at the time of informed consent
- •Asian patients aged 18 to 60 with mild to moderate atopic dermatitis (EASI score 0 to 21) regardless of gender
- •Patients who have not changed the therapeutic drug for atopic dermatitis from 1 month before obtaining informed consent and do not plan to change the therapeutic drug during the study period (there is no limit on the change in the amount used)
- •Patients who have not been treated for comorbidities that affect atopic dermatitis
- •Patients who can practice the instructed usage on their own
- •Patients who can go to the outpatient clinic according to the study implementation schedule
- •Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study
排除标准
- •Patients who have experienced hypersensitivity or contact dermatitis to materials used in facial machine
- •Patients with erosions and ulcers on the face
- •Patients with malignant tumors (however, this does not apply if the tumor has been cured by surgery or other means)
- •Patients with significantly different skin conditions/symptoms on both sides of the face (Patients with a difference of 30 or more in EASI score between the left and right faces)
- •Patients using any of the following medical electrical devices: pacemakers and other implantable medical electrical devices, artificial heart lungs and other life-supporting medical electrical devices, and electrocardiographs and other wearable medical electrical devices
- •Patients with heart disease, disorders, or suspected heart disease
- •Patients unable to express their own will
- •Patients unable to perceive sensations of temperature or stimulation
- •Non-Asian patient
- •Patients who are judged inappropriate for participation in this study by the principal investigator or co-investigator
结局指标
主要结局
EASI score
时间窗: 8 weeks after the start of the study
The difference in the average rate of change in the EASI (Eczema Area and Severity Index) score on the face between the side using the facial device and the non-using side
次要结局
- IGA score on the face
- EASI score on the face
- Water content in the stratum corneum of the face
- Transepidermal water loss
- Skin surface pH
- Sebum content
- Skin elasticity
- Melanin/erythema content
- Skin texture evaluation
- Skin color
- Skin blood vessel evaluation
- Image analysis of skin by facial imaging device
- Width of nasolabial folds and wrinkles around eyes
- Visual inspection evaluation score by Skin Aging Scale for Asians
- Changes in the volume of the forehead, cheeks, corners of the mouth, and face line
- QOL survey
- Scores from skin condition questionnaire and product questionnaire
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