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临床试验/NCT05128916
NCT05128916Unknown3 期

Efficacy of Intralesional Platelet-rich Plasma in Treatment of Onychomycosis: a Randomized Controlled Trial

Sohag University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年12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
75
试验地点
1
主要终点
Onychomycosis severity index

研究概览

简要总结

This study aims to investigate efficacy of intralesional PRP in treatment of finer nail onychomycosis.

详细描述

Onychomycosis is a challenging medical condition with limited response to oral antifungal drugs. Recent study demonstrated that platelet rich plasma (PRP) have immuno-enhancing and antimicrobial properties. It had been shown that platelet microbicidal proteins released after platelet activation demonstrate potent activities against many gram-negative, gram-positive, and fungal pathogens in vitro and in vivo studies.

In addition, white blood cell concentration in PRP was reported to be two to fourfold their normal level in whole blood. Neutrophils release myeloperoxidase which has a defensive action against fungi and bacteria, while lymphocytes and monocytes both are immunogenic cells (Badade et al., 2016). Recently, PRP was successfully used in the treatment of multiple recalcitrant plane warts (Abu El-Hamd et al., 2021), Also, PRP proved its efficacy in inhibiting periodontal pathogens such as P. gingivalis and A. actinomycetemcomitans (Badade et al., 2016). In addition, relevance of platelets for antifungal defenses might be suggested by the fact that thrombocytopenia represents a highly significant risk factor for fungal infections in post-transplant liver patients (Chang et al., 2000).

This study compares between intralesional RPR versus oral antifungal versus intralesional PRP + oral antifungal in the treatment of finger nail onychmycosis.

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)

盲法说明

Due to the nature of interventions (oral versus intralesional), both patient and treating investigator will not be blinded, but the assessment of outcome will be carried out by two dermatologists who will be blinded to the treatment type.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants will be adult patients (> 18 years) with onychomycosis confirmed by dermoscopy, direct KOH microscopic examination and positive culture..

排除标准

  • Patients with one or more with the following criteria will be excluded.
  • Pregnant and lactating women.
  • Patients received topical and/or systemic antifungal therapy during the previous 3 months.
  • Patients with impaired liver or renal functions.
  • Patients with anemia (hemoglobin level <10mg/dl), thrombocytopenia (platelet count < 100,000 /µL), coagulopathies or patients on anticoagulant therapy as aspirin and patients with iron deficiency.

研究组 & 干预措施

Intralesional PRP

Active Comparator

Patients with onychomycosis will receive intralesional injections of PRP.

干预措施: intralesional platelet rich plasma (Biological)

Oral terbinafine

Active Comparator

Patients with onychomycosis will receive oral terbinafine 250 mg daily

干预措施: Oral terbinafine (Drug)

Intralesional PRP + Oral terbinafine

Active Comparator

Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily.

干预措施: intralesional platelet rich plasma (Biological)

Intralesional PRP + Oral terbinafine

Active Comparator

Patients with onychomycosis will receive intralesional PRP in addition to oral terbinafine 250 mg daily.

干预措施: Oral terbinafine (Drug)

结局指标

主要结局

Onychomycosis severity index

时间窗: 3 months

It is a quantitative score used to define the severity of onychomycosis. Briefly, OSI score is obtained by multiplying a score for the area of involvement (range, 0-5) by a score for the disease proximity to the matrix (range, 1-5). Ten points are added for the presence of a longitudinal streak or a patch (dermatophytoma) or greater than 2 mm of subungual hyperkeratosis. Mild onychomycosis corresponds to a score of 1- 5; moderate onychomycosis corresponds to a score of 6- 15, and severe onychomycosis corresponds to a score of 16- 35(Carney et al., 2011).

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

Reem Elhaddad Ali

Assistant lecturer of Dermatology, Venereology and Andrology

Sohag University

研究点 (1)

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