A Clinical Trial to study effects of tofacitinib and oral mini pulse(betamethasone) in moderate to very severe alopecia areata patients

Comparison of Effectiveness between Oral Tofacitinib Versus Oral Mini Pulse in the Treatment of Moderate to Very Severe Alopecia Areata : A Randomized Open- Label Study - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057476

Enrollment

Registered

2023-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: L63- Alopecia areata

Interventions

Intervention1: tofacitinib: ? 5 mg BD by oral route for 3 months Control Intervention1: betamethasone: ? 5 mg through oral route on consecutive 2 days in a week for 3 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient willing to give consent. 2. 18-70 years old. 3. Moderate to very severe alopecia areata -according to SALT Score as below SALT SCORE SEVERITY OF AA 0% No Hair Loss 1-20% Limited 21-49% Moderate 50-94% Severe 95-100% Very Severe

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation. 2. Patients with uncontrolled liver, renal, cardiovascular, hematological or connective tissue disorders. 3. Contraindication to oral tofacitinib or oral steroid. 4. Patients received systemic treatment within 1 month before presenting to our Out Patient Department.

Design outcomes

Primary

Measure	Time frame
•comparison of average percentage scalp hair regrowth by using the formula-[ Initial SALT Score- Follow up SALT Score/ initial SALT Score ]x 100 •Side effects in two groups. Timepoint: •3 months	—

Secondary

Measure	Time frame
• Comparison of percentage of patients who achieved SALT-50. • Percentage of patients showing cosmetically acceptable hair regrowth. • Percentage of patients not responding, defined by not achieving SALT-50. • Percentage of patients showing relapse. Relapse is defined as any loss of regrown hair or new alopecia areata patches during follow-up. • Change in dermoscopic features from baseline. Timepoint: 3 months & 6 months	—

Measure

Time frame

• Comparison of percentage of patients who achieved SALT-50. • Percentage of patients showing cosmetically acceptable hair regrowth. • Percentage of patients not responding, defined by not achieving SALT-50. • Percentage of patients showing relapse. Relapse is defined as any loss of regrown hair or new alopecia areata patches during follow-up. • Change in dermoscopic features from baseline. Timepoint: 3 months & 6 months

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Countries

India

Contacts

Public Contactsoumi biswas

Nil Ratan Sircar medical college

arunachar655@gmail.com8777240233

Outcome results

None listed

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