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Enrolling by Invitation

NCT Number: NCT07050810

Thera-Clean® Microbubbles System in Patients With Skin Diseases

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.

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Key information

Conditions

Epidermolysis Bullosa Atopic Dermatitis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Ichthyosis Immune System Diseases Infant, Newborn, Diseases Keratosis Psoriasis Skin Abnormalities Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TheraClean

Device

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.

Other names: Thera-Clean® Microbubbles bath system

Primary outcomes

  1. 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

    IGA will be assessed on a 4-point scale: clear; almost clear; mild; moderate; severe.

Secondary outcomes

  1. 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

    assessed between baseline and Week 4 and Week 8

  2. 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

    assessed between baseline and Week 4 and Week 8

  3. Change in Peak Pruritus/Pain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale)

    Time frame: 8 weeks

    assessed between baseline and Week 4 and Week 8

  4. Change in odor as assessed by subject reported odor assessment questionnaires.

    Time frame: 8 weeks

    assessed between baseline and Week 4 and Week 8

  5. Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey.

    Time frame: 8 weeks

    assessed throughout the study

  6. Overall satisfaction of device / device usage as assessed by subject reported satisfaction survey.

    Time frame: 8 weeks

    assessed throughout the study

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Thera-Clean® Microbubbles System: A Pilot Study in Patients With Skin Diseases

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 3, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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