Comparison of Laser Photobiomodulation and Topical 0.05 percentage Clobetasol Propionate in the treatment of Oral lichen planus :A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Reduction in pain severity measured using the Visual Analog Scale and reduction in lesion severity assessed using the REU score that is Reticulation Erythema Ulceration
研究概览
简要总结
Oral Lichen Planus (OLP) is a chronic mucocutaneous condition commonly affecting the oral mucosa, often associated with burning sensation and discomfort. Topical corticosteroids, such as clobetasol propionate, are considered the standard treatment. However, their long-term use may result in adverse effects. Photobiomodulation therapy (PBM), using low-level laser therapy, has emerged as a non-invasive alternative with potential anti-inflammatory and analgesic effects.
This interventional, parallel-group clinical trial aims to compare the efficacy of PBM and topical clobetasol propionate in patients diagnosed with symptomatic oral lichen planus. A total of 44 participants will be randomly allocated into two groups: one receiving PBM and the other treated with clobetasol 0.05% ointment. Outcomes will be assessed using Visual Analog Scale (VAS) for pain and REU score (Reticulation, Erythema, Ulceration) for lesion severity over a period of 2weeks,4 weeks and one month.
The study seeks to evaluate whether PBM can provide similar or superior symptom relief with fewer side effects compared to conventional steroid therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator 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
- •Normal physical examination results before medication.
排除标准
- •Presence of severe systemic diseases or other severe oral mucous diseases or under cancer treatment Previous history of photobiomodulation therapy History of anti-inflammatory drugs treatment within a month Presence of lichenoid reaction caused by amalgam fillings or drugs known to cause drug induced lichenoid reaction Pregnancy intention of pregnancy lactation or recent use of steroid hormone based contraceptives OLP patients with skin lesions History of psychiatric disorders Participation in any other clinical trials in the 3 months before enrollment in this study Those lesions with epithelial dysplasia in histopathological evaluation Patient who are allergic to the drugs used in the study.
结局指标
主要结局
Reduction in pain severity measured using the Visual Analog Scale and reduction in lesion severity assessed using the REU score that is Reticulation Erythema Ulceration
时间窗: At baseline 2 weeks 4 weeks after 1 month
次要结局
未报告次要终点