Comparison of two drugs - Baricitinib and Tofacitinib for treatment of alopecia areata

Comparative Efficacy of Baricitinib and Tofacitinib in Extensive Alopecia Areata - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058673

Enrollment

130

Registered

2023-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L639- Alopecia areata, unspecified

Interventions

Intervention1: Tofacitinib and Baricitinib: Clinical assessment - SALT, Eyebrows and eyelash assessment score, Nail involvement shall be done. Laboratory assessments: CBC, LFT, KFT, Lipid profile, Che

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive patients of Alopecia areata between ages 12 years ( >40kgs weight) -50 years, with disease duration of less than 10 years and history of current episode of at least 6 months with no evidence of spontaneous regrowth, and with severity scoring [as measured by Severity of Alopecia Tool (SALT)] of >20, shall be included (including alopecia totalis and alopecia universalis).

Exclusion criteria

Exclusion criteria: 1. Those with a history of intake of systemic or intralesional steroids or any other immunosuppressant drug in the preceding 2 months or of a JAK inhibitor within past 3 months 2. History of active tuberculosis in last 3 years, significant co-morbid conditions, pregnant and lactating women shall be excluded. 3. Co-existence of other forms of alopecia

Design outcomes

Primary

Measure	Time frame
To compare proportion of patients in each group achieving SALT 50 (50% improvement in SALT from baseline) at 12 and 16 weeksTimepoint: 12 weeks and 16 weeks	—

Secondary

Measure	Time frame
1. To compare proportion of patients achieving SALT 90 (90% improvement in SALT from baseline) at 12 weeks and 16 weeks 2. To compare proportion of patients achieving SALT 75 (75% improvement in SALT from baseline) at 12 weeks and 16 weeks 3. To compare proportion of patients achieving SALT 4. To compare the percentage change in SALT score from baseline in the two groups 5. To compare adverse event profile among groups 6. Proportion of patients with improvement in Eyebrow assessment score 7. Proportion of patients with improvement in Eyelash assessment score 8. Proportion of patients with improvement in nail involvement Timepoint: 12 weeks and 16 weeks	—

Measure

Time frame

1. To compare proportion of patients achieving SALT 90 (90% improvement in SALT from baseline) at 12 weeks and 16 weeks 2. To compare proportion of patients achieving SALT 75 (75% improvement in SALT from baseline) at 12 weeks and 16 weeks 3. To compare proportion of patients achieving SALT 4. To compare the percentage change in SALT score from baseline in the two groups 5. To compare adverse event profile among groups 6. Proportion of patients with improvement in Eyebrow assessment score 7. Proportion of patients with improvement in Eyelash assessment score 8. Proportion of patients with improvement in nail involvement Timepoint: 12 weeks and 16 weeks

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Countries

India

Contacts

Public ContactAnanta Khurana

Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital

drananta2014@gmail.com9212370467

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026