atopic dermatitis
Conditions
Interventions
Acute ozonated water bath group:Once-daily ozonated water baths + 2 times daily moisturizer (good skin gel), last 6 days.
Acute tap water bath group:Once-daily tap water baths + 2 times daily moisturizer (good skin gel), last 6 days.
chronic ozonated water bath group:The controlled study period will last for 2 weeks (ozone hydrotherapy every other day + Euzoll bid+ moisturizer bid). Finished treatment for 2 weeks control study sub
chronic tap water bath group:The controlled study period will last for 2 weeks (tap water baths every other day + Euzoll bid+ moisturizer bid). Finished treatment for 2 weeks control study subjects wi
Sponsors
the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
0.2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. The parents/legal guardian must provide a copy of signed and dated informed consent; 2. Male or female subjects must be = 3 months and = 6 years old at the time of signing the informed consent; 3. At the time of screening, subjects confirmed that AD met the consensus criteria of the American Academy of Dermatology (i.e., modified Hanifin & Rajka AD criteria); 4. At screening, IGA score of 2 or 3 (mild to moderate), EASI score of 1.1-21 (mild to moderate), and area of AD lesions (excluding scalp lesions but including facial lesions) 3%=BSA=20%; 5. Participants were willing and able to comply with scheduled visits and treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following criteria were not eligible for inclusion in the study: 1. Diseases that interfere with the evaluation of test results, such as immune dysfunction, severe renal and liver dysfunction, serious cardiovascular disease, malignant tumor, acute and chronic infection; 2. Nearly 1 month system use of antibiotics, hormone and immune inhibitors, biological agents, JAK inhibitor; 3. Accompanied by mental illness or unable to cooperate in treatment; 4. Patients with clear uncontrolled parasitic infection; 5. There were any uncontrolled clinically significant laboratory abnormalities that were considered by the investigator or sponsor to affect the interpretation of data or the participant's participation in the study. 6. Have participated in a clinical study of another investigational drug within 3 months before starting study drug treatment, or are still within 5 half-lives (if known) of the investigational drug from the previous clinical trial, whichever is longer. In 3 months involved in test instrument is used to study or is still in the follow-up of the study of longer (to) of the subjects are from the need to rule out in this study. 7. Required receipt of a prohibited concomitant drug or receipt of a prohibited concomitant drug within the specified window before the first dose of a study drug. 8. Research center to participate in this study the researchers and their family members, the researchers regulation research center staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator’s Global Assessment Scale;Eczema area and severity index;peak pruritus NRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| SCORing Atopic Dermatitis;Dubois Brothers' Body Surface Area;Sleep Quality NRS;The Children’s Dermatology Life Quality Index ;The Infants‘ Dermatitis Quality of Life Index;Patient-Oriented Eczema Measure (POEM) scores ;Dermatitis Family Impact;allergen detection;Full set of immune test;Blood routine test;Blood biochemistry; | — |
Countries
China
Contacts
Public ContactJinrong Zeng
the Third Xiangya Hospital, Central South University
Outcome results
None listed