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NCT07050810

Thera-Clean® Microbubbles System in Patients With Skin Diseases

StatusEnrolling by Invitation
PhaseEarly Phase 1
Primary completion (estimated)

At risk: Primary completion moved at least 5 months later.

See at-risk trials from Northwestern University

Track this trial

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 5 words
    • Primary completion pushed from Dec 2026 to Jun 2027
    • Study completion pushed from Feb 2027 to Aug 2027
    • Secondary endpoints: details revised at 5 of 6 entries
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Aug 2025 to Jan 13, 2026
    • Primary completion date: Aug 2026 to Dec 2026
    • Site contact updated
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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).
Timeframe: 8 weeks

Secondary (6)

Change in subject's/proxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires.
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)
Change in Peak Pruritus/Pain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale)
Change in odor as assessed by subject reported odor assessment questionnaires.
Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey.
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Overall satisfaction of device / device usage as assessed by subject reported satisfaction survey.

Arms and interventions

At Home Bath with TheraClean deviceExperimental

Participants treated with Thera-Clean Microbubbles bath system

Devices: TheraClean

Sites

1 site in 1 country

  • Northwestern University Department of DermatologyChicago, Illinois, United States