Assess the efficacy of two antifungal medicated nail lacquers: Ciclopoli® (ciclopirox 8%) and Loceryl® (amorolfine 5%) on fungi eradication by means of cultural test of onychomycotic big toenails.
- Conditions
- distal subungual onychomycosis without lunula involvement due to fungal nail pathogens (dermatophytes, white yeasts and/or Scopulariopsis spp. and/or Fusarium spp.) affecting at least one big toenailTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-003087-70-LV
- Lead Sponsor
- Polichem SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Written informed consent before starting any study related procedures
Patients aged 18 up to 75 years old
Males or females
Patients with established clinical diagnosis of distal sub-ungual onychomycosis caused by fungal nail pathogens, affecting at least one big toenail with indication for topical treatment
Patients with both positive KOH and culture for fungal nail pathogens (dermatophytes, white yeasts and/or Scopulariopsis spp. and/or Fusarium spp.) in screening target nail sample.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Patients with Yellow spikes on the target nail (extension of fungal infection from distal to proximal part of nail)
Patients with lunula involvement (marker of immunosuppressed patient)
Patients with negative KOH examination at screening
Patients with proximal subungual involvement (marker of immunosuppressed patient)
Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate)
Patients with nail abnormalities due to conditions like psoriasis or lichen planus
Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to study drug administration until the end of the study.
Patients with target nail hyperkeratosis exceeding 4 mm in thickness
Use of any topical antifungal drugs (including investigational drug) or participation in an investigational study within 30 days prior to administration of study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the conversion to negative of culture of treatment with Ciclopoli® vs Loceryl® .<br><br>;Secondary Objective: To evaluate the conversion to negative of culture at week 4 and 8, 24 and 48.<br>To evaluate the conversion to negative of KOH microscopy at week 4, 8, and 12, 24 and 48.<br>To evaluate the clinical signs of onychomycosis at week 4, 8, and 12, 24 and 48.<br>Responders rate at week 12, 24 and 48, defined as patients with conversion to negative of culture and of microscopic KOH examination and with decrease of affected nail area to =10% of total.<br>Complete cure rate at week 12, 24 and 48 defined as complete replacement of the affected nail by new healthy nail, accompanied by conversion to negative of culture and of microscopic KOH examination).<br>To evaluate the overall safety and local tolerability.;Primary end point(s): Conversion to negative of culture.;Timepoint(s) of evaluation of this end point: twelve weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Conversion to negative of culture evaluated at 4, and 8, 24 and 48 weeks<br>Conversion to negative of microscopy (KOH), monitored at 4, 8, and 12, 24 and 48 weeks.<br>Determination of nail infected area at weeks 4, 8 and 12, 24 and 48 compared to baseline<br>Determination of growth rate of healthy nail at weeks 4, 8, and 12, 24 and 48.<br>Responders rate at week 12, 24 and 48 defined as patients with conversion to negative of culture and of microscopic KOH examination and with decrease of affected nail area to =10% of total<br>Complete cure rate at week 12, 24 and 48 defined as complete replacement of the affected nail by new healthy nail, accompanied by conversion to negative of culture and of microscopic KOH examination).<br>Overall safety evaluation;Timepoint(s) of evaluation of this end point: 4, 8, 12, 24 and 48 weeks