An Early Phase 1 interventional study of TheraClean in Epidermolysis Bullosa, Ichthyosis and Atopic Dermatitis, sponsored by Northwestern University. Enrolling by invitation at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Northwestern University · Early Phase 1, Interventional, and Treatment
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.
85 studies on the registry are indexed under Epidermolysis Bullosa; 17 are open to participants now.
This study's planned enrollment of 20 is above the median of 14 across 67 interventional studies indexed under Epidermolysis Bullosa.
Browse Epidermolysis Bullosa studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants treated with Thera-Clean Microbubbles bath system
Device: TheraClean
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.
Also known as: Thera-Clean® Microbubbles bath system
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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