Distal subungual onychomycosis (DSO) MedDRA version: 9.1 Level: LLT Classification code 10030338 Term: Onychomycosis
Conditions
Interventions
Product Name: K101
Product Code: K101
Pharmaceutical Form: Cutaneous solution
CAS Number: 57-55-6
Other descriptive name: PROPYLENE GLYCOLE
Concentration unit: % (W/W) percent weight/weight
Concentrat
Sponsors
Moberg Derma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is the proportion of patients with mycological cure of the target nail (defined as negative fungal culture and negative direct KOH microscopy) at 12 months treatment + 2 weeks washout (visit 12). ;Main Objective: The primary objective of the study is to evaluate the efficacy of topical K101 in adults with distal subungual onychomycosis compared to placebo after 12 months treatment +2 weeks washout. The primary efficacy variable is the proportion of patients with mycological cure of the target nail (defined as negative fungal culture and negative direct KOH microscopy) at 12 months treatment + 2 weeks washout (visit 12).;Secondary Objective: Secondary objectives are to evaluate the efficacy and safety of K101 compared to placebo. Secondary efficacy variables: •Mycological cure of target nail at 6 and 15.5 months •Fungal culture of target nail at 6, 12.5 and 15.5 months •Direct KOH microscopy of target nail at 6, 12.5 and 15.5 months •Length of unaffected target nail at 3, 6, 9, 12.5 and 15.5 months •Physician´s Global Evaluation Score (GES) of target nail at 1, 3, 6, 9, 12.5 and 15.5 months •Patient’s subjective score of all treated nails except the little toenail at 1, 3, 6, 9, 12.5 and 15.5 months. •Proportion of patients with complete cure (simultaneous mycological cure and Physician´s GES=5) of target nail at 6, 12.5 and 15.5 months | — |
Countries
Sweden
Outcome results
None listed