Distal subungual onychomycosis (DSO) MedDRA version: 9.1 Level: LLT Classification code 10030338 Term: Onychomycosis
Conditions
Interventions
Product Name: Kaprolac 70
Product Code: K70
Pharmaceutical Form: Cutaneous solution
CAS Number: 57-55-6
Other descriptive name: PROPYLENE GLYCOLE
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Moberg Derma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·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
Exclusion criteria
Exclusion criteria: ·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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of topical Kaprolac® K70 in adults with distal subungual onychomycosis with a target nail involvement of = 50% at baseline compared to placebo after 6 months treatment +2 weeks washout. The primary efficacy variable is the proportion of patients with mycological cure (defined as negative fungal culture and negative direct microscopy) at 6 months treatment +2 weeks washout.;Secondary Objective: Secondary objectives are to evaluate the efficacy of Kaprolac® K70 compared to placebo separately in patients with a target nail involvement of = 50% and in patients with an involvement of 51-75% at baseline. Safety and tolerability of Kaprolac® K70 will be assessed in all patients together irrespective of target nail involvement at baseline.;Primary end point(s): The primary objective of the study is to evaluate the efficacy of topical Kaprolac® 70 in adults with distal subungual onychomycosis with a target nail involvement of = 50% at baseline compared to placebo after 6 months treatment +2 weeks washout. | — |
Countries
Poland, Sweden
Outcome results
None listed