Randomized, open-label, controlled study on the efficacy of Ciclopoli® (ciclopirox 8% nail lacquer) versus Loceryl® (amorolfine 5% nail lacquer) on the culture conversion to negative in patients with onychomycosis.

Polichem SA0 个研究点目标入组 120 人开始时间: 2011年10月11日最近更新: 2015年12月22日

适应症

试验速览

暂无简介。

•Written informed consent before starting any study related procedures
•Patients aged 18 up to 75 years old
•Males or females
•Patients with established clinical diagnosis of distal sub-ungual onychomycosis caused by fungal nail pathogens, affecting at least one big toenail with indication for topical treatment
•Patients with both positive KOH and culture for fungal nail pathogens (dermatophytes, white yeasts and/or Scopulariopsis spp. and/or Fusarium spp.) in screening target nail sample.
•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 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Patients with Yellow spikes on the target nail (extension of fungal infection from distal to proximal part of nail)
•Patients with lunula involvement (marker of immunosuppressed patient)
•Patients with negative KOH examination at screening
•Patients with proximal subungual involvement (marker of immunosuppressed patient)
•Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate)
•Patients with nail abnormalities due to conditions like psoriasis or lichen planus
•Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to study drug administration until the end of the study.
•Patients with target nail hyperkeratosis exceeding 4 mm in thickness
•Use of any topical antifungal drugs (including investigational drug) or participation in an investigational study within 30 days prior to administration of study medication

发起方

Polichem SA