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临床试验/NCT06327620
NCT06327620招募中不适用

A Novel Alternative Treatment Of Oral Lichen Planus

Mansoura University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Clinical Improvement of Oral Lichen Planus Lesions

研究概览

简要总结

This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.

The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.

Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug.

Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis.

The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition.

详细描述

This clinical study aims to explore a novel alternative treatment for oral lichen planus (OLP) utilizing Daivobet ointment, a combination of calcipotriol and betamethasone. The protocol is designed to provide in-depth technical information on patient selection, treatment procedures, clinical assessments, and statistical analyses, ensuring a comprehensive understanding of the study's methodology.

Patient Selection:

Fifteen patients aged 30-60 with bilateral intra-oral erosive lichen planus symptoms will be recruited from the department of Oral Medicine and Diagnosis at the Faculty of Dentistry, Kafr Elsheikh University. Participants with a history of unresponsiveness to current therapies will undergo histopathological confirmation through incisional biopsy.

Inclusion Criteria:

Presence of bilateral oral erosive lichen planus lesions. Clinical and histopathological diagnosis of oral lichen planus based on a modified definition of the World Health Organization (WHO).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 30-60 years. Clinical signs and symptoms of bilateral intra-oral erosive lichen planus. History of unresponsiveness to currently available therapy. Histopathological confirmation by incisional biopsy. Willingness to topically apply Daivobet ointment in one side and topical steroid in the other side three times daily for 4 weeks.

排除标准

  • Histological signs of dysplasia. Use of drugs possibly causing a lichenoid reaction. Lesions in contact with dental amalgam restorations. Any topical or systemic medications used in the treatment of oral lichen planus within four weeks before the study.
  • History of hypersensitivity to the drug used in the current study.

研究组 & 干预措施

Daivobet Ointment

Experimental

Daivobet Ointment Arm: Patients in this arm will be asked to topically apply Daivobet ointment three times daily for four weeks

干预措施: Daivobet ointment, topical steroids (Combination Product)

Topical steroids

Active Comparator

Patients in this arm will be asked to topically apply a steroid ointment three times daily for four weeks.

干预措施: Daivobet ointment, topical steroids (Combination Product)

结局指标

主要结局

Clinical Improvement of Oral Lichen Planus Lesions

时间窗: End of the second and fourth weeks of treatment.

Assessment of the degree of clinical improvement based on the reduction in the severity of oral lichen planus lesions.

次要结局

  • Objective Response Score(End of the second and fourth weeks of treatment)
  • Subjective Response Score(Start of the study and at the end of the second and fourth weeks of treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaa Saleh

Assistant professor

Mansoura University

研究点 (2)

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