alopecia areata
Conditions
Interventions
Ematinib Treatment Group :Pharmacological Intervention with Ematinib
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Pediatric subjects with alopecia areata aged 2 to 18 years (inclusive), regardless of gender, were stratified into 3 age strata: 2 to 6 years (Toddler Group), 7 to 16 years (Child Group), and 17 to 18 years (Adolescent Group). 2.Meet the diagnostic criteria for moderate-to-severe alopecia areata, which is primarily characterized by a scalp hair loss area of >=21%. 3.The current disease duration of alopecia areata is more than 6 months, with no spontaneous improvement observed in the past 6 months (i.e., the SALT score dropping to <=10 points). 4.The subjects or their legal guardians sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with mild alopecia areata, which is primarily characterized by a scalp hair loss area of <21%. 2. Androgenetic alopecia, telogen effluvium, and other types of alopecia; 3. Subjects with rheumatoid arthritis and other autoimmune diseases; 4. Having infectious diseases such as hepatitis B and tuberculosis; 5. Subjects allergic to Ematinib or any of its components; 6. In the investigator’s judgment, subjects whose legal guardians lack credibility or have poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with severe alopecia areata and moderate alopecia areata with SALT scores <= 20 and <= 10, respectively, at different age groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Children's Depression and Anxiety Scale (Parent Version) Score;ClinRO Nail score;Dermatology Life Quality Index;ClinRO EL score;ClinRO EB score; | — |
Countries
China
Contacts
Public ContactYang Xichuan
The First Affiliated Hospital of Army Medical University
Outcome results
None listed