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A study to compare the efficacy of topical Tacrolimus cream and topical Tofacitinib ointment in patients with alopecia areata single patch

Comparative study of efficacy and tolerability of topical therapy with 0.03% Tacrolimus cream versus 2% Tofacitinib ointment in patients of Alopecia Areata single patch in a tertiary care teaching hospital: A prospective, observational study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097722
Enrollment
44
Registered
2025-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: L638- Other alopecia areata

Interventions

Intervention1: Topical Tofacitinib: The topical medication in this study group will be advised to be applied once daily on affected lesion. The total period of study will be 24 weeks. Follow up will b

Sponsors

Department of Health Research under MoHFW
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: NOT APPLICABLE

Exclusion criteria

Exclusion criteria: Multiple patches or diffuse alopecia. History of autoimmune, systemic, or endocrine disorders (e.g., SLE, thyroid disease). Current use of systemic immunosuppressants or corticosteroids. Patient known for study drug hypersensitivity reaction. History of cancer. Positive tests for hepatitis B or C virus, tuberculin skin test, QuantiFERON TB test, and human immunodeficiency virus. Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint will be the difference in the composite Severity of Alopecia Tool (SALT) scale from baseline to 24 weeks.Timepoint: At the end of 24 weeks

Secondary

MeasureTime frame
1. Safety assessment done by recording and evaluating the spontaneously reported adverse events by the participants. 2. To assess and compare patient s quality of life (QoL) using Dermatology Life Quality Index (DLQI) from baseline to 24 weeks between two groups Timepoint: The secondary efficacy endpoint will be the difference in the Dermatology Life Quality Index (DQLI) from baseline to 24 weeks.

Countries

India

Contacts

Public ContactDr Sayali Rodge

GMC Nagpur

gosavipunam@gmail.com09284244063

Outcome results

None listed

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