NCT07050810

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
9mo left

Started Jan 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

June 16, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

June 16, 2025

Last Update Submit

January 30, 2026

Conditions

Epidermolysis BullosaIchthyosisAtopic DermatitisPsoriasis

Outcome Measures

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).

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

    8 weeks

Secondary Outcomes (6)

  • Change in subject's/proxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires.

    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)

    8 weeks

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

    8 weeks

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

    8 weeks

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

    8 weeks

  • +1 more secondary outcomes

Study Arms (1)

At Home Bath with TheraClean device

EXPERIMENTAL

Participants treated with Thera-Clean Microbubbles bath system

Device: TheraClean

Interventions

TheraCleanDEVICE

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
At Home Bath with TheraClean device

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Epidermolysis BullosaIchthyosisDermatitis, AtopicPsoriasis

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VesiculobullousInfant, Newborn, DiseasesKeratosisDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, Papulosquamous

Study Officials

  • Amy Paller, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2025

First Posted

July 3, 2025

Study Start

January 13, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)