Comparison of two drugs - Baricitinib and Tofacitinib for treatment of alopecia areata
- Conditions
- Health Condition 1: L639- Alopecia areata, unspecified
- Registration Number
- CTRI/2023/10/058673
- Lead Sponsor
- Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.To compare proportion of patients achieving SALT 90 (90% improvement in SALT from baseline) at 12 weeks and 16 weeks <br/ ><br>2.To compare proportion of patients achieving SALT 75 (75% improvement in SALT from baseline) at 12 weeks and 16 weeks <br/ ><br>3.To compare proportion of patients achieving SALT <10 at 12 weeks and 16 weeks <br/ ><br>4.To compare the percentage change in SALT score from baseline in the two groups <br/ ><br>5.To compare adverse event profile among groups <br/ ><br>6.Proportion of patients with improvement in Eyebrow assessment score <br/ ><br>7.Proportion of patients with improvement in Eyelash assessment score <br/ ><br>8.Proportion of patients with improvement in nail involvement <br/ ><br>Timepoint: 12 weeks and 16 weeks