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临床试验/NCT04332796
NCT04332796已完成4 期

A Study of Efficacy of Chlorhexidine Scrub, ZnO Nanoparticles Socks and the Combination of Chlorhexidine Scrub and ZnO Nanoparticles Socks for Treatment of Pitted Keratolysis

Mahidol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3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
状态
已完成
入组人数
60
试验地点
1
主要终点
The number of patients who had improvement of pitted lesion after treatment

研究概览

简要总结

This study aimed to study the efficacy of chlorhexidine scrub, zinc oxide nanoparticles (ZnO-NPs) socks and the combination of chlorhexidine scrub and ZnO-NPs socks in treatment of pitted keratolysis.

详细描述

Introduction Pitted keratolysis is a common skin disease, caused by various gram-positive bacteria including Corynebacterium species, Kytococcus sedentarius, Dermophilus congolensis and Actinomyces species. These bacteria create small tunnels in the stratum corneum, causing pitted lesions at plantar areas. This condition is frequent accompanied by feet malodor and is commonly found in young male adults, especially in soldiers, miners and athletes. The reported prevalence of pitted keratolysis among naval cadets in Thailand was 38.7%. Predisposing factors related to pitted keratolysis are pedal hyperhidrosis and prolonged feet occlusion. Although this condition is generally not painful, our previous study in 2018 revealed adversely affects patients' quality of life.

Regarding treatment modalities of pitted keratolysis, various medications and life-style modification have been recommended. Previous studies revealed efficacy of topical choices, including benzoyl peroxide gel, clindamycin-benzoyl peroxide gel, glycopyrrolate cream, erythromycin gel, clindamycin solution, chlorhexidine scrub and mupirocin ointment. Oral antibiotics and botulinum toxin injection were also beneficial in pitted keratolysis. As to life-style modification, wearing cotton socks and opened footwear, and proper hygiene, have also been suggested.

Zinc oxide (ZnO) has been demonstrated to exhibit antimicrobial activities against many microorganisms, such as Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa and fungal infections including dermatophytosis. It has been proposed that the mechanism is the generation of reactive oxygen species, such as hydrogen peroxide, on microorganism cell surfaces, thereby causing membrane dysfunction. The antimicrobial activities have been observed to vary with changes in the physical and chemical properties of ZnO, for instance, its particle size, porosity and specific surface area.

Nanobiotechnology , which is the integration of biotechnology and nanotechnology, is currently being used in drug delivery systems. The bactericidal efficacy of ZnO nanoparticles (ZnO-NPs) has been shown to improves with a decrease in their particle size. ZnO has also been shown to be is safe and compatible with human skin, which makes it a suitable additive for textiles. Research by Choopong and Sarayut established that ZnO-NP-coated socks exhibited antimicrobial activities against gram-positive (S. aureus) and gram-negative (Klebsiella pneumoniae) bacteria.

Objective This study aimed to study the efficacy of chlorhexidine scrub, zinc oxide nanoparticles (ZnO-NPs) socks and the combination of chlorhexidine scrub and ZnO-NPs socks in treatment of pitted keratolysis.

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 (Investigator, Outcomes Assessor)

盲法说明

Single blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.

入排标准

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

入选标准

  • Male security guards and hospital porters , who had pitted keratolysis

排除标准

  • Male security guards and hospital porters who previously received any topical treatment including topical antibiotic, antiperspirant or aluminum chloride within 2 weeks prior to the study.

研究组 & 干预措施

Chorhexidine scrub

Active Comparator

Chorhexidine scrub was given to patients for 4 weeks

干预措施: Chorhexidine scrub (Drug)

ZnO-NPs socks

Active Comparator

ZnO-NPs socks to patients for 4 weeks

干预措施: ZnO-NPs socks (Device)

Combination of chorhexidine scrub and ZnO-NPs socks

Active Comparator

Chorhexidine scrub and ZnO-NPs socks to patients for 4 weeks

干预措施: Combination of chorhexidine scrub and ZnO-NPs socks (Combination Product)

结局指标

主要结局

The number of patients who had improvement of pitted lesion after treatment

时间窗: 4 weeks

Effectiveness was evaluated

次要结局

  • The percentage of patients developed any side effect such as erythema, burning(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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