Topical Calcipotriol Gel Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia: Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- clinical improvement in oral leseions
研究概览
简要总结
The goal of this clinical trial is to learn if calcipotriol and photodynamic therapy are equally effective in treatment of leukoplakia or not. The main questions it aims to answer are:
do lesions decrease or disappear when treated by calcipotriol or PDT? does the drug affect the salivary biomarkers
Participants will:
Take calcipotriol daily for 4 weeks or perform 4 PDT sessions over 4 weeks measure changes in salivary biomarkers be followed up for 3 months
详细描述
Oral leukoplakia (OL) is a prevalent, potentially malignant disorder of the oral mucosa, characterized by white patches that cannot be scraped off and are not attributable to any other definable disease. Affecting a significant portion of the adult population, OL carries a considerable risk of malignant transformation to oral squamous cell carcinoma (OSCC). Current management strategies for OL range from watchful waiting and surgical excision to various topical and systemic pharmacological interventions, all with varying degrees of success and potential side effects. Topical calcipotriol gel helps reverse dysplastic changes (OL) by promoting normal cell differentiation. Photo dynamic therapy using 5- aminolevulonic acid can selectively destroys abnormal cells. Treatment effectiveness can be monitored non-invasively through salivary levels of Matrix metallo proteinases-9 (MMP-9) and Tumor necrosis factor-alpha (TNF-α), biomarkers that reflect disease progression and treatment response.
Aim: Evaluate and compare the effectiveness of topical calcipotriol gel and photodynamic therapy using 5- aminolevulonic acid as a photosensitizer in the regression of OL which will be measured by a clinical score. The impact of these treatment modalities on levels of salivary MMP-9 and TNF-alpha will also be investigated. Materials and Methods: A randomized clinical trial will be carried out on 30 patients diagnosed clinically with OL and histologically confirmed dysplasia. Group I (n=15 patients) will be treated using topical calcipotriol gel 0.005% twice daily for 4 weeks.
Group II (n=15 patients) will be treated by photodynamic therapy using 635nm diode laser and 20% aminolevulonic acid gel. Each point will receive 3 minutes of irradiation at 500 mW/cm2 power density at a dosage of 150 J/cm2. Lesions will be evaluated clinically at baseline,,2,4,8 and 12 weeks using Femiano et al clinical scoring key. Salivary levels of MMP-9 and TNF-α will be evaluated at baseline, 4 and 12 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, both males and females, 25 to 55years old will be included in this clinical trial.
- •Patients with oral leukoplakia with histologically confirmed mild and moderate epithelial dysplasia.
- •Patients willing and able to return for multiple follow up visits
排除标准
- •Presence of any visible oral lesions other than leukoplakia.
- •Periodontitis patients: since chronic periodontitis may affect salivary TNF-alpha and MMP-9 level.
- •Contraindications for the use of calcipotriol or amino levulonic acid as allergy.
- •History of topical and/or systemic therapy for 2 months before the start of study.
- •Patients with conditions that could affect saliva collection as xerostomia.
研究组 & 干预措施
calcipotriol arm
patients recieved topical calcipotriol gel for 4 weeks and assess salivary biomarkers at 0, 4 and 12 weeks later
干预措施: Calcipotriol 0.005% gel (Drug)
photodynamic therapy arm
patients will recieve 4 sessions of 5 aminolevulonic acid mediated photodynamic therapy over 4 weeks and assess salivary biomarkers at 0 , 4 and 12 weeks
干预措施: ALA mediated PDT (Device)
结局指标
主要结局
clinical improvement in oral leseions
时间窗: 0,4 and 12 weeks
measuring reduction in size in cm using periodontal probe or endo ruler before and after treatment
次要结局
- changes in salivary biomarkers before and after treatment(0,4, and 12 weeks)
研究者
Farida Reayd
assistant lecturer of oral medicine and periodontology
Alexandria University