Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Clinical appearance of the lichen lesion
研究概览
简要总结
The investigators want to study the effect of clobetasol in symptomatic oral lichen planus. The investigators will include 90 patients and randomly allocate them in three groups. The first group will receive active treatment both in the morning an evening. Group two receives placebo in the morning and active treatment in the evening. Group three will get placebo both in the morning and in the evening. All Groups will follow the same protocol with rinsing twice daily with test substance in conjunction with antifungal treatment. The patients will be controlled after two weeks and and again after another two weeks. A biopsy will be performed at inclusion and another biopsy will be taken at the end of the test period. Smears for candida will also be evaluated. The patients will be examined for changes in clinical appearance and will answer questions to note changes in symptoms. Our hypotheses: #Patients receiving clobetasol will have a better resolution af symptoms than those who got placebo. #Patients treated with clobetasol twice daily will have a faster relief of symptoms than patients just treated once daily. #The clinical signs of oral lichen planus will diminish more pronounced in the two groups given active treatment. #A majority of the OLP lesions were infected by candida. #Specific histological changes can be seen in the biopsies taken after clobetasol treatment compared to those taken before treatment.
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
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic oral lichen planus
- •Age above 40 years
排除标准
- •Lichenoid contact lesions
- •Graft versus host disease
- •Bacteria related lichenoid reaction
- •Intraoral vesiculobullous diseases
- •Active antibiotic treatment
- •Active treatment with steroids or other immunomodulating substance
- •Allergy to Clobetasol
- •Severe periodontitis
- •Bad oral hygiene
- •Biopsy not supporting OLP
- •Allergy to nystatin
- •Not in menopause
- •Previous or actual oral malignancy
- •Participation in other medical study
研究组 & 干预措施
Active/active
The one bottle for use in the morning has clobetasol-oral gel, and so does the bottle fore use in the evening. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
干预措施: Clobetasol Propionate (Drug)
Placebo/active
The bottle for use in the morning contains placebo and one for use in the evening contains clobetasol oral gel. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
干预措施: Placebo/Klobetasol APL oral gel 0.025% (Drug)
Placebo/placebo
Both bottles, the one for the morning and the one for use in the evening, contains placebo. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical appearance of the lichen lesion
时间窗: Four weeks
Site-, severity- and activity-score according to Escudier et al
次要结局
- Burning sensation score(Four weeks)
- Candida(baseline (At treatment start))
- Histological appearance(Four weeks)
- Oral health impact profile(Four weeks)
- Pain score(Four weeks)
研究者
Fredrik Gränse
Dentist
Malmö University