Comparative effectiveness of topical Roflumilast 0.3 percent vs Triamcinolone acetonide 0.1 percent in symptomatic Oral Lichen Planus patients: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- appearance of normal mucosa (Score 2 on Thongprasom scale),pain and Burning sensation (VAS 3).
研究概览
简要总结
OBJECTIVES OF THE STUDY-
1. Assess the effectiveness of topical Roflumilast 0.3% in the management of Oral Lichen Planus.
2. Tocompare the effectiveness of topical Roflumilast 0.3% and triamcinolone acetonide 0.1% in the management of Oral lichen planus.
Source of data
Data will be collected from patients reporting to the Out-Patient Unit of Oral Medicine and Radiology in the Faculty of Dental Sciences, I.M.S., B.H.U. Patientsfulfilling the inclusion criteria (stated below) will be selected. Diagnosis of OLP would be based on the patient’s history, clinical features, and histopathological confirmation by biopsy
Sampling technique- Simple Randomised Sampling
Sample size determination-
The sample size was estimated using the data (internal resorption) obtained from a previous study conducted by Zirwas MJ et al with a=0.05 and power of study 80%, the sample size calculated was n=32 samples per group.
**Study design -**Randomized control trial with concurrent parallel design.
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Diagnosis of patient of Oral Lichen Planus will be made clinically as well as histologically. Pain will be recorded using VAS (Visual Analog Scale) and clinical signs and symptoms will be recorded using RAE Score used by Thongprasom and co-workers (Reticular, Atrophic, Ulcerative).
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An informed consent and treatment to be given will be explained to the patient before including in either group.
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Baseline scoring of pain and clinical signs and symptoms will be recorded.
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Patients will then be divided randomly into two groups i.e control group and the experimental group.
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Patients in the control group will be given topical corticosteroid (0.1% triamcinolone acetonide), topical application 3 times daily with no food or fluid intake 1hour after application for 2 weeks. Follow-up will be done every week but VAS and RAE scoring once a month and at baseline (i.e baseline,1 month, 2 months, 3 months).
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Patients of the experimental group will be treated with topical ROFLUMILAST 0.3% topical application 2 times daily with no food or fluid intake 1hour after application for 2 weeks. Follow-up will be done every week but VAS and RAE scoring once a month and at baseline (i.e baseline,1 month, 2 months, 3 months).
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VAS and RAE scoring will be done every month and at baseline (i.e baseline,1month,2months,3 months).
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Comparative evaluation of VAS and RAE scores will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of both gender and age between 18 years to 60 years, will be diagnosed with symptomatic lesions of reticular, atrophic, and erosive oral lichen planus based on clinical, histopathological criteria by WHO.
- •Patients who give informed consent after explaining the treatment type will be included in the study.
排除标准
- •Patients with any other Potentially Malignant Oral Disorders (PMOD) will be excluded.
- •Pregnant females and breastfeeding mothers will be excluded.
- •Patients with a history of corticosteroids, NSAIDs, or any other treatment in the last 30 days will be excluded.
- •Treatment with any drug or restoration that may include lichenoid reaction.
- •Patients with other systemic diseases or illnesses will be excluded.
结局指标
主要结局
appearance of normal mucosa (Score 2 on Thongprasom scale),pain and Burning sensation (VAS 3).
时间窗: Baseline, 1 month, 2 months, 3 months
次要结局
- normal mucosa (Score 0),absence of pain and BS (VAS 0)(Baseline, 1 month, 2 months, 3 months)
研究者
KRITIKA TIWARI
Faculty of Dental Sciences Institute of Medical Sciences Uttar Pradesh