Alopecia areata (including alopecia totalis and alopecia universalis) Skin and Connective Tissue Diseases
Conditions
Interventions
Participants are randomly allocated in a 1:1 ratio to one of two parallel treatment groups. Randomisation was performed using a computer-generated block randomisation sequence in a 1:1 ratio. Allocati
Sponsors
University of Jeddah
Jordanian Universities Network (Jordan)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis 3. No treatment with Janus kinase inhibitors during the previous 6 months 4. Able and willing to provide informed consent and comply with all study visits and procedures
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Active autoimmune disease contraindicating Janus kinase inhibitor therapy 3. Positive tuberculosis screening (Quantiferon) 4. Positive hepatitis screening 5. Abnormal baseline laboratory findings including LDL >150 mg/dL, triglycerides >200 mg/dL, total cholesterol >200 mg/dL, AST >37 U/L, or ALT >37 U/L 6. Hypercalcemia 7. Vitamin D toxicity 8. Recent malignancy 9. Active systemic infection 10. Current systemic immunosuppressive therapy 11. Known secondary vitamin D deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of alopecia measured using Severity of Alopecia Tool (SALT) at baseline, 6 months, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and treatment-related adverse events measured using clinical assessment, adverse event reporting, and laboratory monitoring (CBC, liver function tests, lipid profile, calcium, and serum vitamin D). at throughout the 12-month study period;Quality of life measured using Dermatology Life Quality Index (DLQI) at baseline, 6 months, and 12 months;Serum 25-hydroxyvitamin D level measured using nmol/L at baseline, 6 months, and 12 months;Treatment adherence measured using patient adherence assessed by treatment compliance and follow-up attendance at throughout the 12-month study period | — |
Countries
Jordan
Contacts
Public ContactAsem;Yara Aldebei;Hammouri
;
Outcome results
None listed