Alopecia Areata, AA
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be 18-65 years of age at the time of informed consent, regardless of gender; 2. Diagnosed with severe alopecia areata (SALT score >=50%, including alopecia totalis/universalis) with disease duration between 6 months and 8 years; 3. Prior inadequate response or intolerance to one systemic treatment (e.g., corticosteroids, immunosuppressants) for cumulative duration of more than 6 months; or inadequate response or intolerance to at least two systemic treatments, each lasting >=3 months; 4. In the investigator's opinion, planned to receive albociclib treatment; 5. Voluntarily provide informed consent prior to any study-related procedure, able to communicate effectively with the investigator, and willing and able to fully understand and strictly comply with the study protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Concomitant androgenetic alopecia or active scalp inflammation; alopecia areata in the recovery phase, excluding other causes of hair loss (e.g., androgenetic alopecia, scarring alopecia, chemotherapy-induced alopecia); 2. Active malignancy or recent history of malignancy; concomitant thrombosis or other autoimmune diseases; 3. Requiring long-term use of corticosteroids, non-steroidal anti-inflammatory drugs, systemic immunosuppressants, or biologic agents; 4. Severe hepatic or renal impairment, or peptic ulcer; 5. Hepatitis, tuberculosis, syphilis, HIV, herpes zoster, or other infectious diseases requiring systemic anti-infective treatment; 6. Having psychiatric or neurological disorders, history of substance abuse, poor compliance, or unwilling/unable to cooperate; 7. Pregnant or lactating women, or women of childbearing potential not using effective contraception; 8. Hypersensitivity to the active ingredient of albociclib or any excipient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alopecia Severity Scoring Tool; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject Global Assessment ; | — |
Countries
China
Contacts
Affiliated Hospital of Guilin Medical University