[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07050810":3,"trial-entities:NCT07050810":92,"trial-summary:NCT07050810":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":45,"sex":60,"minimum_age":61,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":71,"locations":75,"central_contacts":85,"overall_officials":86,"references":90,"see_also_links":91},"NCT07050810","STU00223929","Thera-Clean® Microbubbles System in Patients With Skin Diseases","Thera-Clean® Microbubbles System: A Pilot Study in Patients With Skin Diseases","ENROLLING_BY_INVITATION","2027-02","2026-01","2026-02-03","2026-01-13","Northwestern University","OTHER",false,"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\u002For 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.",null,[19,20,21,22],"Epidermolysis Bullosa","Ichthyosis","Atopic Dermatitis","Psoriasis",[],"INTERVENTIONAL","TREATMENT",[27],"EARLY_PHASE1",{"count":29,"type":30},20,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DEVICE","TheraClean","Begins after Week 0 visit and continues through Week 8. Participants will take at least 3 baths\u002Fweek (20-30 minutes each bath) but may bathe daily, if desired.",[37],"At Home Bath with TheraClean device",[39],"Thera-Clean® Microbubbles bath system",[41],{"measure":42,"description":43,"timeFrame":44},"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",[46,49,51,53,55,58],{"measure":47,"description":48,"timeFrame":44},"Change in subject's\u002Fproxy's perceived visibility and severity of skin disease as assessed by subject reported severity and visibility questionnaires.","assessed between baseline and Week 4 and Week 8",{"measure":50,"description":48,"timeFrame":44},"Overall improvement in the Dermatology Life Quality Index (>16 yo)\u002F Children or Proxy-reported Children Dermatology Life Quality Index (4-15 yo)\u002F Proxy-reported Infant Dermatology Life Quality Index (CDLQI\u002FDLQI\u002FIDLQI) (\u003C4 yo)",{"measure":52,"description":48,"timeFrame":44},"Change in Peak Pruritus\u002FPain Numeric Rating Scale and Peak Pain Numeric Rating Scale scores (0-10 scale)",{"measure":54,"description":48,"timeFrame":44},"Change in odor as assessed by subject reported odor assessment questionnaires.",{"measure":56,"description":57,"timeFrame":44},"Overall tolerability of device \u002F device usage throughout study as assessed by subject reported tolerability survey.","assessed throughout the study",{"measure":59,"description":57,"timeFrame":44},"Overall satisfaction of device \u002F device usage as assessed by subject reported satisfaction survey.","ALL","2 Years",{"inclusion":63,"exclusion":66,"raw_text":70},[64,65],"Patients 2 years of age or above with psoriasis, atopic dermatitis\u002Feczema, 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)",[67,68,69],"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","Inclusion Criteria:\n\n* Patients 2 years of age or above with psoriasis, atopic dermatitis\u002Feczema, epidermolysis bullosa, or ichthyosis\n* 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)\n\nExclusion Criteria:\n\n* Patients with unstable skin conditions\n* Patients not willing to comply with the study requirements for bathing at home\n* Patients younger than 2 years of age",[72,73,74],"CHILD","ADULT","OLDER_ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Northwestern University Department of Dermatology","Chicago","Illinois","60611","United States",{"lat":83,"lon":84},41.85003,-87.65005,[],[87],{"name":88,"affiliation":13,"role":89},"Amy Paller, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":93,"biomarkers":94},[21,19,20,22],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]