A Randomized, Single-Blinded, Comparative Study of Mycosinate and Curanail in the Treatment of Fungal Nail Infection

ektr Technologies0 个研究点目标入组 60 人开始时间: 2018年7月4日最近更新: 2021年5月17日

适应症

试验速览

暂无简介。

•Confirmed presence of hyphae through microscopy of nail sample taken from patient. (Further details of nail sampling given in section 2.7.5)
•In good overall health (Subject to Health Assessment conducted by the responsible Physician).
•Male and Female aged between 18-65 inclusive.
•The fungal infection is seen across 20-75% of the nail with no involvement of the lunula. (Details of nail sizing protocol given in section 2.8.1)
•Subject is willing and available to return for study follow ups.
•Subject is willing to discontinue use of cosmetic nail products for the duration of the study.
•Subjects must agree to refrain from using other nail fungus treatments for the duration of the study
•Physical examination without significant deviations.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Diabetics.
•Severe cases of onychomycosis (e.g. complete coverage of nail).
•Chronic conditions such as immune deficiency, chronic vascular disease or psoriasis.
•Currently involved in another clinical trial.
•Patients who are pregnant or breastfeeding.
•Severe secondary dermal infections
•Patients suffering from proximal subungual onychomycosis
•Any medical condition which may place the patient at risk of infection or delayed wound healing
•Patients using immunosuppressant drugs
•Other conditions known to cause an abnormal nail appearance
•Known allergy to any of the ingredients in the study treatments
•Patient has been using any antifungal therapy for the removal of the infection, either systemic or topical, in the past 6 months.
•Patients who have damaged or broken periungual skin.

发起方

ektr Technologies