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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Begins after Week 0 visit and continues through Week 8. Participants will take at least 3 baths/week (20-30 minutes each bath) but may bathe daily, if desired.
Northwestern University Department of Dermatology
Chicago, Illinois, United States
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).
IGA will be assessed on a 4-point scale: clear; almost clear; mild; moderate; severe.
Time frame: 8 weeks
Change in subject's/proxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires.
assessed between baseline and Week 4 and Week 8
Time frame: 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)
assessed between baseline and Week 4 and Week 8
Time frame: 8 weeks
Change in Peak Pruritus/Pain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale)
assessed between baseline and Week 4 and Week 8
Time frame: 8 weeks
Change in odor as assessed by subject reported odor assessment questionnaires.
assessed between baseline and Week 4 and Week 8
Time frame: 8 weeks
Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey.
assessed throughout the study
Time frame: 8 weeks
Overall satisfaction of device / device usage as assessed by subject reported satisfaction survey.
assessed throughout the study
Time frame: 8 weeks
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