Thera-Clean® Microbubbles System: A Pilot Study in Patients With Skin Diseases
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement of skin condition between baseline to Week 4 and baseline to Week 8 using Thera-Clean® microbubble bathing therapy as assessed by the Investigator Global Assessment (IGA).
研究概览
简要总结
Thera-Clean® Microbubble has proved to improve skin conditions in animals, however little research has been done regarding human subjects. Microbubble technology is a chemical-free therapeutic aimed at clearing foreign and organic matter from hair follicles, eliminating odors, and reducing itch. This hydrotherapy is said to aid in the healing process of inflamed and distressed tissue, relieve pain, and serve to remove contaminated tissue. This study will evaluate the change in skin conditions from the use of Thera-Clean® Microbubble for cleansing and debriding wounds from selected subjects focused on patients with inflammatory skin disease (epidermolysis bullosa, ichthyosis, atopic dermatitis and/or psoriasis). Proper wound care to prevent infection is vitally important for these patients and the options of therapeutics are limited. This study will evaluate the change in skin conditions from the use of Thera-Clean® Microbubble for cleansing and debriding lesional skin.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 2 years of age or above with psoriasis, atopic dermatitis/eczema, epidermolysis bullosa, or ichthyosis
- •Skin conditions to be stable for at least the previous 4-week period (patients will continue to use their typical skin treatment regimen throughout the study)
排除标准
- •Patients with unstable skin conditions
- •Patients not willing to comply with the study requirements for bathing at home
- •Patients younger than 2 years of age
研究组 & 干预措施
At Home Bath with TheraClean device
Participants treated with Thera-Clean Microbubbles bath system
干预措施: TheraClean (Device)
结局指标
主要结局
Improvement of skin condition between baseline to Week 4 and baseline to Week 8 using Thera-Clean® microbubble bathing therapy as assessed by the Investigator Global Assessment (IGA).
时间窗: 8 weeks
IGA will be assessed on a 4-point scale: clear; almost clear; mild; moderate; severe.
次要结局
- Change in Peak Pruritus/Pain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale)(8 weeks)
- Change in odor as assessed by subject reported odor assessment questionnaires.(8 weeks)
- Overall improvement in the Dermatology Life Quality Index (>16 yo)/ Children or Proxy-reported Children Dermatology Life Quality Index (4-15 yo)/ Proxy-reported Infant Dermatology Life Quality Index (CDLQI/DLQI/IDLQI) (<4 yo)(8 weeks)
- Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey.(8 weeks)
- Change in subject's/proxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires.(8 weeks)
- Overall satisfaction of device / device usage as assessed by subject reported satisfaction survey.(8 weeks)
研究者
Amy Paller
Principal Investigator
Northwestern University