A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex®
研究概览
简要总结
This study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.
详细描述
Onychomycosis is the common superficial fungal skin infection in general population. According to the previous study, the prevalence of tinea pedis and onychomycosis in general Thai population were 3.8% and 1.7% respectively. However, this problem has been neglected for treatment due to asymptomatic clinical manifestations and low effects in quality of life.
In Thailand, the previous studies reported that the aetiological pathogens of this disorder were non-dermatophyte mold (51.6%), dermatophyte (36.3%) and yeast (6%). Additionally, Scytalidium dimidiatum was the majority causative agents in non-dermatophyte mold.
Systemic therapy such as azoles group and terbinafine is recommended for the standard management of tinea capitis. In contrast, a prolonged course may be induce serious side effects. So that topical therapy is the alternative treatment in older patients who are limited in drug usage. Especially, non-dermatophyte onychomycosis is the recalcitrant condition. Moreover, none of the standard regimen is recommended.
Nailprotex® is the novel topical treatment in onychomycosis and chronic paronychia. The active ingredient is phenol which is extracted from Olea European leaf. It is able to inhibit the fungal growth. Additionally, this product has been applied for nail care in many European countries over 10 years. The serious side effects have never been reported. Therefore, this study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants was 18 years old or above.
- •Participants were diagnosed Scytalidium dimidiatum onychomycosis or chronic paronychia by dermatologists based on clinical presentation and mycological identification.
- •Participants accept the aim of this project and sign the consent form by themselves.
排除标准
- •Participants have other nail disorders before participate the research.
- •Participants have the history of immunocompromised host.
- •Participants were diagnosed onychomycosis more than 3 nails or matrix involvement.
研究组 & 干预措施
Edit arms
Nailprotex apply to the abnormal nail twice daily
干预措施: Nailprotex (Drug)
结局指标
主要结局
The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex®
时间窗: 6 months
Patients who were treated by Nailprotex® in this study were evaluated the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline and after using Nailprotex® 6 months. Then the change in SCIO score was analyzed in percentage and compare mean.
次要结局
- The side effects of Nailprotex®(6 months)
- Mycological cure rate which mean KOH and fungal culture result are both nagative after using Nailprotex® at 6 month after treated with Nailprotex®(6 months)