Childhood subacute eczema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: There are 1. those who meet the diagnostic criteria for subacute eczema; 2.those aged 2 to 12 years old; 3. those whose skin lesion body surface involvement area is = 4 points, and an IGA score of 2 or 3 points at the time of screening; 4.The informed consent process should comply with regulations, and the legal guardian or the participant (>=8 years old) together with the trial participant should sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Those with severe exudation on the affected area (EASI lesion morphology score Ei >= 2 points) or lichenoid changes (EASI lesion morphology score L >= 2 points); 2.Those with or combined with the following diseases that are difficult to distinguish from eczema, such as superficial fungal diseases, scabies, polymorphous light eruption, psoriasis, seborrheic dermatitis, irritant contact dermatitis, etc.; 3.Those who have received systemic use of glucocorticoids, immunosuppressants and ultraviolet therapy within 4 weeks before treatment, have used antihistamines within 2 weeks before treatment, and have used topical medications (such as TCS, TCI) within 1 week before treatment; 4.Those with obvious bacterial, fungal or viral infections in the lesion area; 5.Those with severe primary diseases or malignant tumors such as cardiovascular, liver, kidney, digestive, hematological and nervous system diseases; 6.Those with legally recognized disabilities (blindness, deafness, dumbness, intellectual disability, mental disorder, etc.); 7.Those who are known or suspected to be allergic to the components of the test drug; 8.Those who have participated in other interventional clinical trials within the past 3 months; 9.Those who, in the opinion of the investigator, are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in the area of target lesions and the changes in the morphology scores of target lesions;Target lesion EASI score and percentage change in body surface area (BSA) of the lesion;Response rates of EASI-50, EASI-75, and EASI-90;Change in IGA score;The success rate of eczema treatment;The proportion of exacerbated eczema cases;Change value of PP-NRS score;Days for itching relief to take effect;Change in POEM score; | — |
Countries
China
Contacts
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine