An open label, single arm, multi-centered study to evaluate the efficacy, safety and tolerability of lipid based tacrolimus ointment 0.1% in patients of oral lichen planus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Change in the Physicians Global Assessment of Clinical Condition from baseline to week 6 / complete healing of all baseline lesions whichever comes first.
研究概览
简要总结
Lichen planus (LP) is a chronic inflammatorymucocutaneous disease that can have both cutaneous and oral involvement affectingthe skin, the tongue, and the oral mucosa. Lichen planus is most commonly foundon the flexor surfaces of the upper extremities, on the genitalia, the nails,and the scalp and on the mucous membranes. At present there is no permanent cure for lichen planus. When itinvolves multiple mucosal surfaces, it becomes more resistant to treatment.Even with the effective treatments, relapses are common. Moreover, patients areunable to tolerate a treatment because of its adverse effects. According to a survey mailed to 40 patientswith symptomatic oral lichen planus treated with topical tacrolimus, mostpatients experienced symptomatic improvement in less than 1 month. Topicaltacrolimus has been reported to be effective for OLP, including those formsthat had been recalcitrant to treatment and disabling. Further, based on thesafety demonstrated in atopic dermatitis trials that included children as youngas age 2 years, topical tacrolimus ointment is apparently a safe, effective,and well-tolerated therapeutic modality. Overall, the lipid based tacrolimusointment approved by the drugs controller general of India for usage in atopicdermatitis is expected to offer a safe and effective therapeutic modality withlong-term benefits for lesions of lichen planus also.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female participants between 18 and 65 years of age 2.Confirmed diagnosis of symptomatic oral lichen planus 3.Symptomatic OLP (Spontaneous or meal related oral pain).
排除标准
- •1.Asymptomatic lichen planus with no ulcerated or erythematous oral lesions.
- •2.Who have received systemic immunosuppressants, oral retinoids or any other systemic therapies known or suspected to have an effect on lichen planus within 4 weeks prior to participation in the study.
- •3.Who have been treated with topical therapy 4.Severe or recurrent systemic or generalized infections (bacterial, viral or fungal).
- •5.Who have unstable or uncontrolled diabetes or hypertension.
- •6.Hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin, etc.
结局指标
主要结局
Change in the Physicians Global Assessment of Clinical Condition from baseline to week 6 / complete healing of all baseline lesions whichever comes first.
时间窗: Baseline to week 6
次要结局
- •Patient’s pain experience measured by means of the Visual Analogue Scale (VAS).(•Patient’s quality of life measured by means of the Oral Health Impact Profile (OHIP - 14).)