A double-blind, placebo-controlled study of efficacy, safety and tolerability of topical Kaprolac® K70 in six months treatment of distal subungual onychomycosis (DSO) - Moberg Derma 2
- Conditions
- Distal subungual onychomycosis (DSO)MedDRA version: 9.1Level: LLTClassification code 10030338Term: Onychomycosis
- Registration Number
- EUCTR2007-001028-11-SE
- Lead Sponsor
- Moberg Derma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
·Male or female (including fertile women)
·18 years or older
·Distal subungual onychomycosis of finger(s) and/or toe(s) affecting = 75% of the nail bed
·Positive culture for dermatophytes (Trichofyton species i.e. T. rubrum or T. mentagrophytes)
·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
·Proximal subungual onychomycosis
·Distal subungual onychomycosis of finger(s) and/or toe(s) where involvement has extended into the proximal portion of the nail, or distal subungual onychomycosis of finger(s) and/or toe(s) affecting >75% of the nail bed
·Conditions known to cause abnormal nail appearance
·Topical treatment of the nails with other antifungal medication within 1 month before screening
·Systemic use of antifungal treatment within 3 months before screening
·Signs of severe peripheral circulatory insufficiency
·Immunosuppression
·Participation in another clinical nail study during the previous 3 months
·Known allergy to any of the tested treatment products or to surgical tape occlusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method