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临床试验/CTRI/2017/08/009375
CTRI/2017/08/009375已完成Unknown

A study of Q-switched Nd:Yag laser in treatment of onychomycosis.

Base Hospital Delhi Cantt1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月7日最近更新:
适应症

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Nail clearance 3mm in 12 weeks

研究概览

简要总结

Onychomycosis, worldwide in distribution accounts for approximately 20-40% percent of all nail disorders.  Individuals wearing shoes for prolonged durations, those with co morbiditieslike diabetes, peripheral vascular disease, HIV, immunosuppression are moreprone to this infection. Further it serves as a source of infection to selfor others and affects the quality of life by causing disfigurement of the nail,pain and discomfort, physical and occupational limitations resulting in negativeeffect on the social, emotional and occupational functioning of the individualand in severe cases may even lead to depression.

Slow growth of the nail along with increasing resistance to anti fungal drugs makes definitive treatment of this condition challenging. Options include debridementof nail; mechanical and chemical palliative care, oral and topical antifungaldrugs, and their various combinations. Choice of treatment depends upon thedisease severity but is subject to relatively high failure rates, is time consumingand costly.The cure rate is only 40-80% even after several monthsof use of potent systemic antifungals which is worse in face of increasingdermatophyte resistance. Oral medications may be associatedwith side effects like vomiting, constipation, headache, drowsiness and skinrash.

Q switched Nd:Yag laser is now approved for management of onychomycosis, however conflicting reports exist in literature about its efficacy. No reports from India exist in such management.

This study was hence conducted with the aim to studythe efficacy of Q Switched Nd Yag laser management of onychomycosis in comparison toItraconazole which is also approved for dermatophyte onychomycosis and is used as an off-labelindication for non-dermatophyte onychomycosis.

The study was initiated with a Null hypothesis that Q switched Nd Yag Laser is not as effective as capsule Itraconazole in management of onychomycosis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Confirmed diagnosis of Onychomycosis in either fungal culture or direct microscopy
  • No history of past treatment.

排除标准

  • Fungal culture negative/failure to demonstrate fungus on nail KOH mount
  • Periungual bacterial infections, subungual hematoma
  • Associated nail disorders which produce changes in the nail plate like psoriasis, pityriasis rubra pilaris, atopic dermatitis and lichen planus
  • Pregnant women
  • Deranged liver functions.

结局指标

主要结局

Nail clearance 3mm in 12 weeks

时间窗: 0,3 months, 12 months

次要结局

  • Onychomycosis severity Index(0, 3 months, 12 months)
  • Visual Analogue Scale(0,3 months, 12 months)

研究者

发起方
Base Hospital Delhi Cantt
申办方类型
Government funding agency

研究点 (1)

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