A double-blind, randomized, multi-centre, placebo-controlled study of efficacy and safety of topical K101 in twelve months treatment of distal subungual onychomycosis (DSO)

Moberg Derma AB0 个研究点开始时间: 2009年7月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Male or female (including fertile women)
•2. 18 years or older
•3. Distal subungual onychomycosis of at least one of the great toe(s) affecting 20% to 60% of the target nail (verified by blinded assessor before randomization)
•4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
•5. Signed written informed consent
•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. Proximal subungual onychomycosis
•2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
•3. ”Spike” of onychomycosis extending to eponychium of the target nail
•4. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
•5. Other conditions than DSO known to cause abnormal nail appearance
•6. Topical treatment of the nails with other antifungal medication within 1 month before screening
•7. Systemic use of antifungal treatment within 3 months before screening
•8. Signs of severe peripheral circulatory insufficiency
•9. Immunosuppression
•10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
•11. Known allergy to any of the tested treatment products
•12. Subject who has been previously randomized to treatment in the phase III study K70-2 investigating K101

发起方

Moberg Derma AB