Health Condition 1: L639- Alopecia areata, unspecified
Conditions
Interventions
Intervention1: Tablet tofacitinib: tablet tofacitinib 5mg twice daily for 24 weeks
Control Intervention1: Oral mini pulse: Tablet betamenthasone 5mg on 2 consecutive days in a week for 16 weeks follow
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a age range of 12-65 years with a clinical diagnosis of Alopecia Areata and a SALT score more than equal to 25% and a current AA episode lasting for more than 6 months and upto 2 years
Exclusion criteria
Exclusion criteria: 1. â??Diffuse ? pattern alopecia areata or other types of alopecia (androgenetic alopecia, scarring alopecias etc.) 2. Patients who had been treated with the following agents: topical steroids on the scalp or eyebrows within 2 week before randomization, systemic or intralesional glucocorticoids (including intraarticular injections) within 4 weeks before randomization, and topical or oral JAK inhibitors within 2 or 4 weeks, respectively, before randomization. 3. Patients who had had an inadequate response to oral JAK inhibitors and/or oral corticosteroids after at least 12 weeks of treatment 4. Pregnant and lactating females 5. Patients with known contra-indications to corticosteroids, such as patients with evidence of active infection, uncontrolled diabetes or uncontrolled hypertension 6. Patients with known contra-indications to oral tofacitinib such as abnormal hematological parameters (Hb less than 9g/dL, platelet count less than 1lac/mm, total leucocyte count less than 400/mm3, lymphocyte count of less than 500 cells/mm3, absolute neutrophil count of less than 1000 cells/mm3), deranged liver function tests (more than 1.5 times the normal range), deranged renal function tests (creatinine clearance less than 40ml/min), dyslipidemia (total cholesterol more than 240mg/dl, triglycerides more than 200mg/dl) 7. Patients with known cardiovascular disease or venous thromboembolism 8. Known patient with HIV, Hepatitis B or C infection or positive on screening 9. History of recurrent or disseminated herpes zoster 10. History of active infection requiring hospitalization or parenteral antimicrobial therapy within 3 months prior to study inclusion 11. Patients not willing to come for monthly follow up visits for 9 months 12. Patients not willing to discontinue other alopecia areata treatments 13. Patients with latent tuberculosis who are not willing to take preventive Anti-tubercular treatment 14. Current or history of malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving equal to more than 50% reduction in SALT score from baseline at week 16Timepoint: Proportion of patients achieving equal to more than 50% reduction in SALT score from baseline at week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 4. Patient reported outcome 0 to 1 for subset of patients with baseline SALT equal to more than 50 Scalp Hair Assessment Patient-Reported Outcome (PRO) score of 0 or 1 (0 to 20% of scalp is missing hair) at week 16, 24 and 36Timepoint: 16, 24 and 36 weeks;1. Mean % reduction in SALT score between the 2 groups at every visitTimepoint: every visit;2. Proportion of patients achieving equal to more than 50% reduction in SALT score from baseline at week 24 and 36.Timepoint: 24 and 36 weeks;3. Proportion of patients with SALT 20 for subset of patients with baseline SALT equal to more than 50 at week 16, 24 and 36Timepoint: 16, 24 and 36 weeks;5. Clinician-Reported Outcome (ClinRO) measure for Eyebrow Hair Loss score of 0 or 1 (full eyebrow coverage or minimal gaps) with a decrease (improvement) of at least 2 points from baseline at week 24 (among patients with a baseline score of equal to more than 2 [with 2 indicating significant gaps and 3 no notable eyebrows]) at week 16, 24 and 36Timepoint: 16, 24 and 36 weeks;6. ClinRO Measure for Eyelash Hair Loss score of 0 or 1 (full eyelash coverage or minimal gaps) with a decrease (improvement) of at least 2 points from baseline at week 24 (among patients with a baseline score of equal to more than 2 [with 2 indicating significant gaps and 3 no notable eyelashes]) at week 16, 24 and 36Timepoint: 16, 24 and 36 weeks;7. Change in mean DLQI scores between two groups at week 16, 24 and 36Timepoint: 16, 24 and 36 weeks;8. Change in activity and hair regrowth trichoscopy markers between two groups at every visitTimepoint: every visit;9. Proportion of patients with a recurrence (more than 25% SALT score increase from the minimum SALT score achieved during treatment) at less than week 36, and between more than 24-36 weeksTimepoint: 24-36 weeks;10. Comparison of adverse events between the two groupsTimepoint: end of study | — |
Countries
India
Contacts
Public ContactDr Vishal Gupta
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed