Atopic Dermatitis (AD)
Conditions
Interventions
Experimental group:Aveeno Baby Dermexa Cream and Standard Patient Education
Control group:Standard Patient Education
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
0.5 Years to 2 Years
Inclusion criteria
Inclusion criteria: 1. Selection criteria: (1) Children from 6 months to 2 year old (<=2 year old), no gender limit; (2) Children with atopic dermatitis who met the AADC (American Academy of Dermatology Consensus) criteria; (3) Mild to moderate atopic dermatitis :IGA<=3(=2/3); EASI score < 16; (4) Bilateral involvement; (5) Recurrent episodes: the number of rash episodes from birth to enrollment was not less than 2 times; (6) The subjects and guardians are willing to use the study drugs in strict accordance with the guidance of the investigator during the whole study period, and do not use other similar products; (7) The guardian of the subject can fully understand the purpose of the trial, voluntarily participate in the trial, sign the informed consent, and cooperate with the clinical follow-up and fill in the diary card. 2. Randomization inclusion criteria: (1) Meeting the inclusion and exclusion criteria during the screening period; (2) IGA score <= 1.
Exclusion criteria
Exclusion criteria: 1. Children with skin diseases other than atopic dermatitis in areas requiring treatment and testing; 2. Children with acute onset, erosion, exudation, and secondary infection; 3. Children who have participated in clinical trials of other drugs or medical devices in the last 3 months; 4. Children with known allergies to hydrocortisone butyrate cream or any component of tested product; 5. Children with wheat allergy; 6. Use emollient for less than 3 days before enrollment; Antihistamine withdrawal time <1 week; Topical corticosteroids or other immunosuppressants for less than 2 weeks; Systemic corticosteroids and other immunosuppressants (cyclosporine, methotrexate, tripterygium wilfordii, etc.) were discontinued for less than 4 weeks; 7. Children with serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system diseases, etc.) and immunodeficiency diseases; 8. Poor compliance; or those who are known to be unable to attend follow-up on time, or unwilling to comply with the research protocol during the study period; 9. Children who were judged by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk of recurrence at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI);Severity of itch (Toronto Pediatric Itch Scale);Infant Eczema Skin Living Index (IDQoL)(Guardian);Patient Oriented Eczema Measure (POEM);Emollient Application Perception Questionnaire;pH of skin;Skin hydration;Transepidermal water loss;Skin microecological changes;Skin lipid profile;Skin proteomics;Investigator's global assessment of skin lesion;Scoring Atopic Dermatitis Index of skin lesion; | — |
Countries
China
Contacts
Public ContactMa Lin
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed