Efficacy of Oral Lycopene in the Management of Oral Lichen Planus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief from signs & symptoms of disease
研究概览
简要总结
the purpose of this study was to evaluate that if lycopene, a potent antioxidant can be used in the treatment of oral lichen planus. this could be useful as lycopene has no reported side effects and hence it can used in place of steroids which are commonly used for this condition and have many reported adverse effects.
lycopene can be used in the treatment of this condition as free radicals have been found to play a role in the cause of this disease and also lower levels of lycopene were seen in these patints.
详细描述
Lichen planus, a chronic inflammatory mucocutaneous disease, occurs in about 2% of the adult population, affecting the skin and or oral mucosa. Clinically, lichen planus appears in keratotic, atrophic or erosive form. The atrophic and erosive forms are usually symptomatic.
Various treatment modalities viz. corticosteroids, antimicrobials, immunomodulators, phenytoin, retinoids, UV-radiation and surgical treatment etc. have been tried. Though none of these have shown to achieve satisfactory results with recurrence of lesion occurring in most of the cases after few weeks of discontinuation of therapy.
Recently a population based case control study has revealed lower levels of lycopene in atrophic and erosive oral lichen planus cases, while no significant difference was noted in any other carotenoid levels.
Lycopene is an antioxidant and free radical scavenger being used in the management of infertility, pre-eclampsia, cataract prevention, osteoarthritis, as adjuvant therapy in various malignancies, cardiovascular disorders, diabetes mellitus, aging, Alzheimer's disease, parkinsonism, etc.
Systemic lycopene has been found to be effective in treatment of oral leukoplakia, owing to its antioxidant properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were physically healthy and well oriented in time space and as a person.
- •Patients clinically & histopathologically diagnosed to be suffering from oral lichen planus.
- •Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus.
- •Patients not on any treatment for the same. In case they were, then such treatment was stopped and a washout period of two weeks was given.
- •Patients who agreed to take medication supplied.
- •Patients who were willing for evaluation once in every two weeks for 8 weeks and also agreed to follow up every 30 days for 60 days.
- •Patients who agreed for the biopsy and hematological examination.
排除标准
- •Patients suffering from any systemic disease/s like Diabetes, Hypertension, Cardiovascular system disease, Renal dysfunction, Liver disorders etc.
- •Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
- •Patients on any drug therapy which may cause lichen planus like lesions.
- •Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure.
- •Patients with a known allergy or contraindication to study medications.
研究组 & 干预措施
A
Patients with symptomatic oral lichen planus
干预措施: Lycopene (Drug)
B
Patients with symptomatic oral lichen planus
干预措施: Placebo (Drug)
结局指标
主要结局
Relief from signs & symptoms of disease
时间窗: 08 weeks
次要结局
- Relief from signs & symptoms of disease(08 weeks)