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临床试验/NCT06135259
NCT06135259尚未招募3 期

Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial

Ain Shams University0 个研究点目标入组 18 人开始时间: 2024年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
18
主要终点
Clinical Scoring

研究概览

简要总结

The purpose of this study is to compare the clinical efficacy of erythropoietin gel containing a solution of 4000 units with triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP)

详细描述

At the first visit before the initiation of the study;

  • Information including age, gender, disease process, medical history, drug history, family history, and clinical symptoms and signs will be documented.
  • Patients will be examined clinically by magnifying mirror using a spotlight for the oral lesions, the distribution of the lesions and the affected areas will be recorded, and a punch biopsy will be taken to confirm the diagnosis.

Twenty-four patients seeking treatment for symptomatic OLP will be assessed for eligibility for this study. Patients will be recruited from the outpatient clinic, department of Oral Medicine and Periodontology, Faculty of Dentistry, and the Department of Skin and Venereal Disease, Faculty of Medicine, Ain Shams University.

The study will be conducted according to the ethical principles provided by the Declaration of Helsinki and according to the principles of good clinical practice. Faculty of Dentistry-Ain Shams University Research Ethical Committee (FD-ASU-RECD) will review the protocol, the procedure will be fully explained to the patients. Each patient will receive detailed verbal and written information about the study protocol. Understanding and agreement to enroll in the study will be confirmed and written consent forms will be obtained.

II- Study design, interventions, blinding, randomization, and grouping:

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 (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Clinically proven painful symptomatic forms of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae)
  • Histopathological proven symptomatic OLP

排除标准

  • History of the drug-induced lichenoid lesion.
  • Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using a medical questionnaire guided by the Cornell Medical Index
  • Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history
  • Pregnancy or breastfeeding.
  • History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications before starting the study
  • Loss of pliability or flexibility in the tissues involved by the lesions of OLP.
  • Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
  • Patients with extensive skin lesions and indicated for systemic corticosteroids.
  • Vulnerable groups (Handicapped, orphans, or prisoners)

研究组 & 干预措施

erythropoietin mucoadhesive thermosensitive hydrogel

Experimental

erythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan (5%) and glycerophosphate (20%).

干预措施: erythropoietin (Drug)

Triamcinolone Mucoadhesive gel

Active Comparator

Each 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.

干预措施: Triamcinolone acetonide (Drug)

结局指标

主要结局

Clinical Scoring

时间窗: The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period

The marker lesion in each patient will be assessed for areas of reticulation, erosion, and ulceration by visual examination and the scoring will be recorded as follow: 0: Mild represented no lesion/normal mucosa. 1. White striae/no erythematous area. 2. White striae with atrophic area less than 1 cm2 3. White striae with atrophic area of more than 1 cm2 4. White striae with an erosive area less than 1 cm2 5. White striae with an erosive area of more than 1cm2

Visual Analogue Score

时间窗: The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period

The Visual Analogue Score consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced). Patients will mark the scale at each visit. The Visual Analogue Score is then scored by measuring from the patient's mark to the beginning of the scale in cm, and all Visual Analogue Score will be included on one sheet of paper allowing the patient to think in terms of change instead of absolutes.

Imaging and measuring surface area of the oral lesion

时间窗: The assessment will be carried out at baseline, 1 and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period

Standardized photographs of the oral marker lesion for each patient will be taken with the same digital camera and setting, and the surface area of the lesion will be outlined and measured using specific image software.

次要结局

  • Tumor necrosis factor Salivary level(The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period.)

研究者

申办方类型
Other
责任方
Sponsor

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