Atopic Dermatitis, Epidermolysis Bullosa, Ichthyosis, Psoriasis
Conditions
Brief summary
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
DEVICETheraClean
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.
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 8 weeks | IGA will be assessed on a 4-point scale: clear; almost clear; mild; moderate; severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in subject's/proxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires. | 8 weeks | assessed between baseline and Week 4 and Week 8 |
| 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 | assessed between baseline and Week 4 and Week 8 |
| Change in Peak Pruritus/Pain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale) | 8 weeks | assessed between baseline and Week 4 and Week 8 |
| Change in odor as assessed by subject reported odor assessment questionnaires. | 8 weeks | assessed between baseline and Week 4 and Week 8 |
| Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey. | 8 weeks | assessed throughout the study |
| Overall satisfaction of device / device usage as assessed by subject reported satisfaction survey. | 8 weeks | assessed throughout the study |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy Paller, MD
Northwestern University
Outcome results
None listed