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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2024
INTERVENTION: 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 acetonide (0.1%): Patients with oral lichen planus in this arm will receive topical triamcinolone acetonide 0.1% paste thrice daily for a period of 6 months. CONDITION: Health Condition 1: L438‐ Other lichen planus PRIMARY OUTCOME: 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 OUTCOME: 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 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
Epistemonikos ID: 193ab495a4d2ce056b7dd72fd1d410ee3274c389
First added on: Apr 09, 2025