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Effect of oral tofacitinib and oral methylprednisolone mini-pulse and combination of both in alopecia areata.

To compare the efficacy and adverse effects of oral tofacitinib and oral methylprednisolone mini-pulse and combination of both in treatment of alopecia areata: A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063353
Enrollment
219
Registered
2024-02-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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: Oral tofacitinib 5 mg twice daily for 4 months Control Intervention1: Oral methylprednisolone 32 mg on two consecutive days per week: Oral methylprednisolone 32 mg on two c

Sponsors

Institute of Medical Sciences BHU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed cases of alopecia areata with severity of alopecia tool (SALT) score of 10 % or over. 2. Age: 18 to 65 years 3. Patients not taking systemic drug in last 1 month and topical treatment in last 15 days. - All participants who give consent for the study

Exclusion criteria

Exclusion criteria: 1. Patients having history or active tuberculosis. 2. Patients with Pregnancy and lactating mother. 3. Patients with uncontrolled renal, hepatic, hematological or heart disease. 4. Patients with diabetes mellitus and hypertension.

Design outcomes

Primary

MeasureTime frame
Reduction in severity of alopecia tool (SALT) score by 90%Timepoint: Reduction in severity of alopecia tool (SALT) score by 90% which will assessed monthly for 4 months.

Secondary

MeasureTime frame
Reduction in severity of alopecia tool (SALT) score by 50% & reduction in severity of alopecia tool (SALT) score by 100%Timepoint: Reduction in severity of alopecia tool (SALT) score by 50% & reduction in severity of alopecia tool (SALT) score by 100% which will be assessed monthly for 4 months.

Countries

India

Contacts

Public ContactDr Bhagirath Bhakar

Institute of Medical Sciences Banaras Hindu University

drsatyendraderma@gmail.com9198120582

Outcome results

None listed

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