Effectiveness of Supplementation With Nail Debridement in Ungual Lacquer Treatment in Podiatry Care on Onychomycosis: Pilot Study of Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- (Potassium hydroxide) KOH and cultivation negative
研究概览
简要总结
Onychomycosis occurs in more than 50% of all pathologies unguinal, affecting the health and quality of life of the patient. Although the investigators have a wide therapeutic arsenal, there is still a disparity when carrying out an effective processing.
Hypothesis/Objectives:
To analyze if the use of the podiatric technique of aggressive unguinal abrasion with micrometer sports, in combination with topical treatment with amorolfin 5% in hairspray, significantly increases the effectiveness clinically as well as mycology.
The investigators will analyze the relationship between this intervention and the quality perception of life related to the health of the nails and the foot.
The investigators will Use results for next validation study in Spanish of the questionnaire NailQoL, as well as validation and reliability of the index SCIO and cost study-effectiveness of the processing.
Method:
The investigators will design a randomized control trial. The town will be recruited, informed prior consent will be obtained from patients of 5 Spanish centers of chiropody, with sample size of 313 patients. There will be a screening of 4 weeks to select patients with onychomycosis infections (clinic and mycology both positives); later the patients will be distributed randomly in 2 groups:
- GROUP AM+AU: Will be administered aggressive unguinal abrasion, weeks 0 (baseline), 12 and 24, followed by standard treatment of amorolfin 5%, two weekly applications during 36 weeks.
- GROUP AM: Will be administered exclusively standard treatment of amorolfin 5%, according to common format. The duration will be 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People of both sexes with ages between 18 and 75 years.
- •Having affected at least the nail out of the first toe of a foot.
- •Having a confirmed diagnosis of onychomycosis with positive and evidence clinic mycology (KOH and Cultivation) both positive ones.
- •The infection should be caused by a fungus dermatology. Will not afford another type of infection because of the possibility of false positives for pollution exogen.
排除标准
- •Having received in 6 previous months some local treatment or systemic for the onychomycosis.
- •Having dystrophies or alterations ungulates, apart from the ones specific to the onychomycosis, that could to interfere in the interpretation of results.
- •Do not have skills for the application and tracking of the topical treatment with the hairspray ungual.
- •Allergy to one of the ingredients of the nail lacquer
- •Pregnancy or breastfeeding situation acquaintances at the time of recruitment.
- •Use of some abrasive or cosmetic product (ej: nail paint) on the treated nail during the tracking of the study.
- •Receiving some type of attendance podology or of Pedicure out of the own ones included in the study.
研究组 & 干预措施
Nail lacquer plus aggressive debridement
Nail lacquer plus aggressive debridement: Will be applied abrasion ungual aggressive, this abrasion will be applied in the beginning of the study, week 0 (baseline), the week 12 and the week 24 and he will follow standard treatment with nail lacquer (Odenil 5%) with 2 weekly applications during 36 weeks.
干预措施: Nail lacquer plus aggressive debridement (Procedure)
nail lacqer alone
Nail lacquer alone: Will be applied exclusively standard treatment with nail lacquer during 36 weeks, according to the usual care
干预措施: Nail lacquer alone (Procedure)
结局指标
主要结局
(Potassium hydroxide) KOH and cultivation negative
时间窗: pre and post intervention and 6 and 12 months of follow up
次要结局
- Clinical improvements of the onychomycosis, valued with SCIO (Scoring Clinical Index for Onychomycosis)(total score, pre and post intervention and 6 and 12 months of follow up)
- Quality of life perception related the onychomycosis and foot health by nailQoL and foot health state questionnaire (FHSQ)(total score, pre and post intervention and 6 and 12 months of follow up)
- Quality of life related general health by euroQol 5-D and SF-12(total score, pre and post intervention and 6 and 12 months of follow up)
研究者
Dr. Antonio I Cuesta-Vargas
PhD
University of Malaga