An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Male or female
18 - 70 years
DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail.
Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
Signed written informed consent
Proximal subungual onychomycosis.
DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
"Spike" of onychomycosis extending to eponychium of the target nail
Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
Other conditions than DSO known to cause abnormal nail appearance
Topical antifungal treatment of the nails within 1 month before screening
Systemic use of antifungal treatment within 3 months before screening
History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy
Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
Known allergy to any of the tested treatment products
A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who :
are pregnant or nursing
are not surgically sterile
are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)