A study to determine the safety and efficacy of a terbinafine topical formulation system in subjects with onychomycosis in laser treated toenails versus ciclopirox lacquer in intact toenails

TLT Medical Ltd.0 个研究点目标入组 235 人开始时间: 2007年1月5日最近更新: 2013年4月22日

适应症

试验速览

暂无简介。

•1)Male or female between 18 and 75 years of age of any race.
•2)Subjects must present with distal/lateral subungual onychomycosis of at least one great toenail at Visit 1 with a degree of involvement of 15% to 75% at screening day.
•3)A positive KOH examination and a positive dermatophyte culture using a validated test from nail specimens taken from the target nails within 20 to 35 days prior to the Day 1 visit.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1)Subjects with nail infections due to organisms other than dermatophytes (e.g. Candida or non-dermatophyte molds) as determined using a suitable culture and proper sampling method; i.e. no mixed infections.
•2)Pregnant or lactating women.
•3)Subjects with known hypersensitivity to terbinafine or ciclopirox or to any of the ingredients in the study drugs.
•4)Subjects with structural deformities of the affected nails, toes or foot that would interfere with the digital photography needed for the planimetric analyses and/or appropriate immobilization of the target toe during the laser treatment.
•5)Subjects that had used oral antifungals (e.g. Lamisil or Sporanox) to treat onychomycosis during the previous 6 months.
•6)Subjects that had used topical antifungal formulation (e.g. Mycoster, Batrafen or Loceryl) to treat onychomycosis during the last 3 months.
•7)Patients with a dermatophytoma.

发起方

TLT Medical Ltd.