Thera-Clean® Microbubbles System in Patients With Skin Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TheraClean.
- Who it may be relevant to
- Registry conditions: Epidermolysis Bullosa, Ichthyosis, Atopic Dermatitis, Psoriasis. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Thera-Clean® Microbubbles System: A Pilot Study in Patients With Skin Diseases
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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). [Time frame: 8 weeks]
Secondary outcome measures (6)
- Change in subject's/proxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires. [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) [Time frame: 8 weeks]
- Change in Peak Pruritus/Pain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale) [Time frame: 8 weeks]
- Change in odor as assessed by subject reported odor assessment questionnaires. [Time frame: 8 weeks]
- Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey. [Time frame: 8 weeks]
- Overall satisfaction of device / device usage as assessed by subject reported satisfaction survey. [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Northwestern University Department of Dermatology — Chicago
Identifiers
NCT: NCT07050810 · STU00223929