Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in pain intensity
研究概览
简要总结
Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh & Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.
详细描述
The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.
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
- Triple (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 suffering from erosive or atrophic OLP
- •Patients free from any visible oral lesions other than OLP.
- •Patients who agreed to take the supplied interventions.
- •Patient who will agree to participate in the study.
- •Patients who will accept to sign the informed consent.
排除标准
- •Patients suffering from any systemic disease.
- •Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
- •Treatment with any oral topical medications for at least four weeks prior to the study.
- •Pregnant and lactating mothers.
结局指标
主要结局
Change in pain intensity
时间窗: baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7
Visual analogue scale (0-10)
次要结局
- change in clinical improvement(baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7)
研究者
Alaa Shousha
Assistant Lecturer
Cairo University