Oral tofacitinib compared with topical triamcinolone acetonide (0.1 percent) paste in patients with symptomatic oral lichen planus: a randomized controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
**Aim:**
To evaluate the efficacy and safety of oral tofacitinib in symptomatic oral lichen planus and compare it with topical triamcinolone acetonide 0.1% paste.
**Primary Objective:**
- Compare the efficacy of oral tofacitinib with topical triamcinolone acetonide 0.1% paste in treating symptomatic oral lichen planus.
**Secondary Objectives:**
-
Compare the safety profile between the two treatment arms.
-
Compare the change in pain score based on the Visual Analogue Scale (VAS).
-
Compare the change in oral health-related quality of life using the Oral Health Impact Profile 14 score (OHIP-14).
**Primary Outcomes:**
-
Proportion of patients achieving a 75% reduction in the Oral Disease Severity Score (ODSS) at the end of 6 months.
-
Proportion of patients achieving a Thongprasom et al. score of 1/2 at the end of 6 months.
**Secondary Outcomes:**
-
Change in pain score based on VAS.
-
Change in oral health-related quality of life using OHIP-14.
-
Percentage change in the clinical scoring system at the end of 6 months.
**Materials and Methods:**
**Study Period:** January 2024 - December 2025
**Study Design:** Open-label randomized controlled trial.
**Study Setting:**
Patients from the outpatient department of the Department of Dermatology, Venereology, and Leprology at PGIMER, Chandigarh, India.
**Sample Size:**
54 patients total, with 30 patients in each arm, accounting for a 10% dropout rate.
**Methodology:**
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Ethics approval and trial registration.
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6 months of active treatment followed by 3 months of follow-up.
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Detailed history, clinical assessment, and photographic documentation at baseline and every 4 weeks.
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Randomization using computer-generated sequences and allocation concealment with SNOSE technique.
**Treatment Regimen:**
-
**Arm 1:** Oral tofacitinib 5 mg twice daily.
-
**Arm 2:** Topical triamcinolone acetonide 0.1% paste thrice daily.
**Assessment:**
-
Monthly clinical assessment using ODSS.
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Responses categorized as excellent (≥75% reduction), good (50-74%), poor (25-50%), or no response (<25%).
This study aims to provide comparative data on the effectiveness and safety of oral tofacitinib versus topical triamcinolone in treating symptomatic oral lichen planus, potentially guiding future treatment protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinician-confirmed diagnosis of symptomatic oral lichen planus having exclusive oral involvement or predominant oral involvement with few cutaneous lesions
- •Patients aged between 18-60 years of age
- •Patients providing informed consent and are willing to follow up monthly for at least 6 months.
排除标准
- •Pregnant and lactating women
- •Women with childbearing potential who are unwilling to follow reliable methods of contraception.
结局指标
主要结局
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
时间窗: 6 months
2. Proportion of patients achieving a Thongprasom et al score of 1/2 at the end of 6 months of therapy
时间窗: 6 months
次要结局
- 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))
研究者
Dr Dipankar De
Postgraduate Institute of Medical Education and Research, Chandigarh