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临床试验/NCT03171584
NCT03171584Unknown3 期

Comparative Study of Systemic Antifungal Drugs Used in Treatment of Onychomycosis

Assiut University0 个研究点目标入组 60 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
60
主要终点
cure rate of patients

研究概览

简要总结

Onychomycosis refers to the fungal infection of the fingernails or toenails, caused by dermatophytes, yeast and non-dermatophyte molds that lead to distortion, discoloration, thickening and detachment from the nail bed

详细描述

Onychomycosis accounts for up to 30% of all superficial infections of skin and constitutes about a half of all nail abnormalities; affecting approximately 5% of population worldwide

The prevalence of onychomycosis is determined by age, social class, occupation, climate, living environment and frequency of travel Despite being common dermatological presentation, the exact prevalence of onychomycosis remains largely unknown.

Toenails are more commonly affected than fingernails due to slower rate of growth of the former, reduced blood supply and usual confinement in dark moist environments The infection is more common in adult males (particularly elderly > 60 yrs of age), diabetics, immunocompromised individuals (e.g. HIV positive), individuals with peripheral vascular (arterial) disease, previous tineapedis infection, history of trauma to the nail, or those with a family history of onychomycosis Dermatophytes whether pathogenic or saprophytes are the commonest causative nail invaders Dermatophytic onychomycosis can be divided into four major clinical types on the basis of their presenting clinical features; distal and lateral subungualonychomycosis (DLSO), proximal subungualonychomycosis (PSO), white superficial onychomycosis (WSO) and total dystrophic onychomycosis (TDO) , Among these,distal and lateral subungualonychomycosis( DLSO) is the most common form.

Clinical diagnosis by physical examination alone can be inaccurate as many non infectious conditions that mimic onychomycosis like lichen planus, psoriasis need to be ruled out . Various laboratory techniques have been used to accurately diagnose onychomycosis, with microscopy by KOH and fungal culture being the most frequently used The histopathology of nail clippings can be utilized for diagnosing onychomycosis, with periodic acid-Schiff (PAS) stain that allows easy visualization of fungal hyphae . Digital dermoscopy, also called onychoscopy, is an easy and quick procedure that allows differential diagnosis of onychomycosis from the common nail dystrophies.

Dystrophic nails can be a social impediment causing significant embarrassment that affects patient's self-esteem. In addition, thickened nails can be painful, interfere with the function of the nail unit and may cause discomfort in walking, standing and exercising.

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
None

入排标准

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

入选标准

  • Patients with finger nail onychomycosis of different sex and age.

排除标准

  • Patients taking immunosuppressive drugs or drugs affecting nail colour or growth.
  • Patients with previous trauma to the nails.
  • Pregnant and lactating women.
  • Patients with 20 nail dystrophy.
  • Patients with keratinization disorders as psoriasis and chronic medical or cutaneous diseases.
  • Patients with chronic medical or cutaneous diseases that may affect quality of life.

研究组 & 干预措施

Fluconazole group

Experimental

Arm (2) will receive Fluconazole (300mg once weekly for 3monthes).

干预措施: Terbinafine (Drug)

Terbinafine group

Experimental

Arm (1) will receive Terbinafine (250mg/day for 6 weeks).

干预措施: Terbinafine (Drug)

Itraconazole group

Experimental

Arm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail)

干预措施: Terbinafine (Drug)

结局指标

主要结局

cure rate of patients

时间窗: one year

Percentage of patients with complete cure in every group

次要结局

未报告次要终点

研究者

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

AMLadeed

A comparative Study of Systemic antifungal drugs used in treatment of onychomycosis

Assiut University

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