Distal and lateral subungual onychomycosis MedDRA version: 8.1 Level: LLT Classification code 10030338
Conditions
Interventions
Product Name: Amorolfine Nail Lacquer New Formulation
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: Amorolfine Hydrochloride
CAS Number: [78613-38-4]
Concentration unit: % (W/V) pe
Sponsors
GALDERMA Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adult aged 18 to 65. 2. Subject with clinically suspected distal and lateral subungual onychomycosis due to dermatophytes and involving at least one great toe nail to be selected as the “Target Toenail” for planimetry. 3. At least one great toenail with at least 25% of the nail surface area with disease involvement but no involvement of the proximal 1/3 of the nail. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject with clinically important abnormality which could interfere with the objectives of the study or the interpretation of the findings. 2. Subject with the presence of spikes or subungual dermatophytoma. 3. Subject with total dystrophic, white superficial or proximal onychomycosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate if there is a difference in efficacy for amorolfine NF at either concentrations, when compared to its vehicle in the treatment of distal and lateral subungual onychomycosis of the toes after 6 months of treatment.;Secondary Objective: - To compare efficacy of amorolfine new formulation (4 and 10%) with the current formulation of amorolfine nail lacquer (Loceryl® 5%) assuming primary objective has been met. - To perform dose ranging evaluation of 2 new formulation concentrations (4% and 10%) - To perform a safety assessment of amorolfine new formulation as compared to its vehicle and current amorolfine formulation. ;Primary end point(s): - Primary Efficacy Endpoint: Clinical Success defined as new unaffected target toe nail length superior or equal to 4 mm at the end of the 6 months treatment period as measured by planimetry. The new unaffected nail length is defined as the increase in millimetres in healthy nail growth from the cuticle as compared to baseline. - Secondary Efficacy Endpoints: % of subjects achieving * Clinical Success at 9 Months * Clinical cure defined as completely cleared target great toe nail as evaluated by investigator using the Global Clinical Effectiveness assessment scale. (ref 6.1.1.3). * Mycological cure defined as Negative Culture. * Global Success defined as combination of Clinical Success and Mycological Cure. * Global Cure defined as combination of Clinical Cure and Mycological Cure. | — |
Countries
Germany, Iceland
Outcome results
None listed