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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003087-70-LV

Enrollment

120

Registered

2011-10-11

Start date

2011-12-02

Completion date

Unknown

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Ciclopoli 8% Nagellack 80mg/g 6,6 ml. Pharmaceutical Form: Medicated nail lacquer INN or Proposed INN: ciclopirox CAS Number: 29342-05-0 Current Sponsor code: P-3051 ciclopirox nail lacque

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the conversion to negative of culture of treatment with Ciclopoli® vs Loceryl® . ;Secondary Objective: To evaluate the conversion to negative of culture at week 4 and 8, 24 and 48. To evaluate the conversion to negative of KOH microscopy at week 4, 8, and 12, 24 and 48. To evaluate the clinical signs of onychomycosis at week 4, 8, and 12, 24 and 48. 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. 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). 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	—

Measure

Time frame

Main Objective: to evaluate the conversion to negative of culture of treatment with Ciclopoli® vs Loceryl® . ;Secondary Objective: To evaluate the conversion to negative of culture at week 4 and 8, 24 and 48. To evaluate the conversion to negative of KOH microscopy at week 4, 8, and 12, 24 and 48. To evaluate the clinical signs of onychomycosis at week 4, 8, and 12, 24 and 48. 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. 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). 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

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Secondary

Measure	Time frame
Secondary end point(s): Conversion to negative of culture evaluated at 4, and 8, 24 and 48 weeks Conversion to negative of microscopy (KOH), monitored at 4, 8, and 12, 24 and 48 weeks. Determination of nail infected area at weeks 4, 8 and 12, 24 and 48 compared to baseline Determination of growth rate of healthy nail at weeks 4, 8, and 12, 24 and 48. 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 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). Overall safety evaluation;Timepoint(s) of evaluation of this end point: 4, 8, 12, 24 and 48 weeks	—

Measure

Time frame

Secondary end point(s): Conversion to negative of culture evaluated at 4, and 8, 24 and 48 weeks Conversion to negative of microscopy (KOH), monitored at 4, 8, and 12, 24 and 48 weeks. Determination of nail infected area at weeks 4, 8 and 12, 24 and 48 compared to baseline Determination of growth rate of healthy nail at weeks 4, 8, and 12, 24 and 48. 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 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). Overall safety evaluation;Timepoint(s) of evaluation of this end point: 4, 8, 12, 24 and 48 weeks

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Countries

Latvia, Russian Federation

Contacts

Public ContactMaurizio Caserini

Polichem S.A.

maurizio.caserini@polichem.com0041919864000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026