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临床试验/NCT04278599
NCT04278599Unknown4 期

Comparative Evaluation of Effect of Oral Zinc Supplementation and Placebo as an Adjuvant to Topical Corticosteroid Therapy in Oral Lichen Planus Patients

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
42
试验地点
1
主要终点
Assessment of changes in size of the lesion

研究概览

简要总结

Lichen planus is an auto-immune, chronic inflammatory disease that affects mucosal and cutaneous tissue. Erosive and atrophic oral lichen planus (OLP) are difficult to manage because patients present with symptoms ranging from episodic pain to severe discomfort and they have the highest malignant transformation rate (MTR) amongst all the forms of OLP. Zinc is associated with regeneration of epithelium, wound healing and mediating T-lymphocyte function; all of which can lead to healing and re-epithelisation in the lesions of erosive OLP. Besides this, it also has anti-oxidant and anti-inflammatory properties, which lead to decrease in apoptosis and transformation into a malignant state.

This study intends to evaluate the effect of oral zinc supplements as an adjuvant to the topical corticosteroid therapy in the treatment of OLP.

详细描述

Lichen planus is a chronic muco-cutaneous disorder of the stratified squamous epithelium that affects the oral and genital mucous membrane, skin, hair, nails and scalp.OLP is the mucosal counterpart of cutaneous lichen planus.The disease was first described by Erasmus Wilson in 1866. The prevelance of disease in the Indian sub-continent is about 2.6%,with the mean age being 30-60 years and with a female predilection. The cutaneous form is more persistent and resistant to treatment while OLP is more frequent in occurrence.

OLP is a potentially pre-malignant oral epithelial lesion. It is a T-cell mediated auto-immune disease in which the auto-cytotoxic CD8 + T cells trigger the apoptosis of the basal cells of oral epithelium.OLP is an idiopathic disease, although there are certain precipitating factors like HLA-A3, anxiety & stress, diabetes and hypertension.

OLP occurs bilaterally, the most common sites being buccal mucosa, tongue, lips, gingiva, floor of mouth and palate. Wickham's striae are a pathogonomic feature. It has six clinical presentations- Reticular, Erosive, Atrophic, Plaque-like, Papular and Bullous.The reticular form is most common but its asymptomatic, while the erosive form is most severe with symptoms ranging from mild burning to severe pain. The range of MTR for OLP is about 0-5%, with the highest rate for erosive and atrophic types.Erosive OLP lesions arise as a complication of the atrophic process after trauma or ulceration. Appear as a central area of erosion with yellowish fibrinous exudate surrounded by erythema, with Wickham's striae in the periphery. Atrophic OLP lesions appear bright red due to loss of epithelium.

A review study done on the recent concepts in the treatment of OLP concluded that corticosteroids (mostly topical, rarely systemic) continue to be the mainstay of management of OLP. However, there are some other drugs which have a significant contribution such as- Calcineurin inhibitors (cyclosporine, tacrolimus, pimecrolimus), Retinoids, Dapsone, Hydroxychloroquine, Mycophenolate mofetil and Enoxaprin. The non-pharmacological treatment modalities include PUVA therapy, photodynamic therapy and laser therapy.

A recently conducted study found out that serum zinc levels were significantly decreased in patients with erosive OLP in comparison with patients of non-erosive OLP, which may be responsible for disintegration of epithelium in erosive OLP lesions.

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinically and histopathologically proven cases of erosive and atrophic OLP.
  • Patients who are willing to participate in the study.

排除标准

  • Patients with reticular form of OLP and OLP with muco-cutaneous involvement.
  • Patients consuming drugs for the treatment of OLP in the past 6 months.
  • Suspected lichenoid reaction associated with drugs and restorations.
  • Patients whose histopathological findings indicate moderate to severe dysplasia.
  • Patients with acquired and congenital immuno-deficiency disorders like AIDS, chemotherapy, addiction to injectable opioids like hemophilia and blood dialysis. These patients are excluded because of difficulty in their biopsy procedure, control of infection, possible interaction with clinical findings of OLP, and their potential doubtful cooperation.
  • Patients with systemic diseases involving the gastro-intestinal tract.
  • Known cases of Acrodermatitis enteropathica where difficulty in zinc absorption persists.
  • Presence of factors that can alter the absorption of zinc like consumption of calcium tablets, iron supplements and high protein diet.
  • Pregnancy and lactation phase
  • Alcoholic patients, since alcoholism results in intracellular zinc deficiency.
  • Recorded allergy to zinc and/or corticosteroids.

研究组 & 干预措施

Test group

Experimental

The patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion.

干预措施: Oral Zinc supplementation (Drug)

Control group

Placebo Comparator

The patients will be administered Placebo tablets for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion.

干预措施: Oral placebo supplementation (Drug)

结局指标

主要结局

Assessment of changes in size of the lesion

时间窗: Baseline, 6 weeks and 3 months.

Thongprasom score (TS) will be used to assess changes in the size of the lesion. Digital Vernier callipers will be used to measure the largest dimension of ulcers at baseline and at each follow-up visit.

Assessment of changes in pain and burning sensation of the lesion.

时间窗: Baseline, 6 weeks and 3 months

Visual Analogue Scale (VAS) will be used to assess changes in pain and burning sensation of the lesion.

Assessment of changes in changes in erythema and ulceration.

时间窗: Baseline, 6 weeks and 3 months

Modified Oral Mucositis Index (MOMI)- will be used to assess changes in erythema and ulceration.

Assessment of quality of life of the patient.

时间窗: Baseline, 6 weeks and 3 months

Oral Health Impact Profile -14 index (OHIP-14) will be used to assess the quality of life of the patient.

次要结局

  • Number of episodes of new lesions in the follow-up period.(Baseline, 6 weeks and 3 months)
  • Adverse effects of oral zinc supplementation.(Baseline, 6 weeks and 3 months)
  • Requirement for additional systemic steroid therapy.(Baseline, 6 weeks and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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