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Thera-Clean® Microbubbles System in Patients With Skin Diseases

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Northwestern University

Status and phase

Invitation-only
Early Phase 1

Conditions

Atopic Dermatitis
Psoriasis
Ichthyosis
Epidermolysis Bullosa

Treatments

Device: TheraClean

Study type

Interventional

Funder types

Other

Identifiers

NCT07050810
STU00223929

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

At Home Bath with TheraClean device
Experimental group
Description:
Participants treated with Thera-Clean Microbubbles bath system
Treatment:
Device: TheraClean

Trial contacts and locations

1

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Central trial contact

Dermatology CTU

Data sourced from clinicaltrials.gov

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