Thera-Clean® Microbubbles System in Patients With Skin Diseases

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis; Psoriasis; Epidermolysis Bullosa; Ichthyosis

• Registration Number: NCT07050810
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Study Start: 2025-08-01
• Primary Completion: 2026-08
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
Overall tolerability of device / device usage throughout study as assessed by subject reported tolerability survey.	8 weeks	assessed throughout the study
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 satisfaction of device / device usage as assessed by subject reported satisfaction survey.	8 weeks	assessed throughout the study

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States