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Comparing Oral Tofacitinib and Topical Triamcinolone Acetonide for Oral Lichen Planus: A Randomized Trial

Oral tofacitinib compared with topical triamcinolone acetonide (0.1 percent) paste in patients with symptomatic oral lichen planus: a randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070729
Enrollment
60
Registered
2024-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: L438- Other lichen planus

Interventions

Intervention1: Tofacitinib: Patients in this arm with oral lichen planus will receive oral tablet tofacitinib 5 mg twice daily for a period of 6 months. Control Intervention1: topical triamcinolone ac

Sponsors

ostgraduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinician-confirmed diagnosis of symptomatic oral lichen planus having exclusive oral involvement or predominant oral involvement with few cutaneous lesions 2. Patients aged between 18-60 years of age 3. Patients providing informed consent and are willing to follow up monthly for at least 6 months

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women 2. Women with childbearing potential who are unwilling to follow reliable methods of contraception

Design outcomes

Primary

MeasureTime frame
1. Proportion of patients achieving 75% reduction in Oral Disease Severity Score (ODSS) proposed by Escudier et al at the end of 6 months of therapy 2. Proportion of patients achieving a Thongprasom et al score of 1/2 at the end of 6 months of therapy Timepoint: 6 months

Secondary

MeasureTime frame
1. Change in pain score based on Visual analogue scale (VAS) 2. Change in oral health-related quality of life based on oral health impact profile 14 score (OHIP-14) 3. Percentage change in the clinical scoring system at the end of 6 months of therapy Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Dipankar De

Postgraduate Institute of Medical Education and Research, Chandigarh

dr_dipankar_de@yahoo.in9316123724

Outcome results

None listed

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