EUCTR2011-003087-70-LV
Active, not recruiting
Not Applicable
Randomized, open-label, controlled study on the efficacy of Ciclopoli® (ciclopirox 8% nail lacquer) versus Loceryl® (amorolfine 5% nail lacquer) on the culture conversion to negative in patients with onychomycosis.
Polichem SA0 sites120 target enrollmentOctober 11, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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 toenail
- Sponsor
- Polichem SA
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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