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A study to compare the effectiveness of Topical Tofacitinib ointment combined with microneedling versus topical Tofacitinib ointment alone in patients of alopecia aerata

A Hospital-based, Randomized Controlled Trial Comparing the Efficacy of topical 2 percent Tofacitinib ointment combined with microneedling versus topical percent ointment alone in treatment of Alopecia Areata - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082382
Enrollment
74
Registered
2025-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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: Tofacitinib with Microneedling: Topical 2 percent Tofacitinib ointment, one fingertip unit to be applied twice daily topically over alopecia patch for 24 weeks and combined with microne

Sponsors

Dr Rohit Singh Chauhan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients between the age group of 18 to 50 yrs Diagnosed with alopecia aerate exhibiting at least two patches of alopecia involving the scalp No history of treatment with microneedling or within 1 month before enrollment in study Willingness to adhere to the study protocol and attend follow-up visits

Exclusion criteria

Exclusion criteria: Active scalp infections or skin diseases systemic immunosuppressive or steroid therapy Known hypersensitivity to tofacitinib or any other study components Prior hair transplantation Any coagulation disorder or thrombocytopenia Patients having alopecia totalis and universalis history of cancer or hepatitis B or C, tuberculin test or IGRA test and HIV virus positive patients pregnant women and children more than 18 years of deranged biochemical profile

Design outcomes

Primary

MeasureTime frame
Percentage improvement in the Severity of the alopecia tool score in both groupsTimepoint: 0, 24 weeks, 48 weeks

Secondary

MeasureTime frame
Trichoscopic findings ( terminal hairs, white dots, black dots, exclaimation mark sign)Timepoint: 0, 6th, 12th month;2. Global photographic assessment at baseline, 6th month and 12th month and comparision between themTimepoint: o, 6th, 12th month;3. Hair pull test and assessment at baseline, 6th month and 12th month and comparision between themTimepoint: 0, 6th, 12th month

Countries

India

Contacts

Public ContactDr Sunil Kumar Gupta

All India Institute of Medical Sciences, Gorakhpuur

dr.sunil_30@yahoo.co.in9838844937

Outcome results

None listed

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