A study with a medicated nail lacquer for the treatment of toenail fungal infectio

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

1. Written informed consent before starting any study related procedures.
2. Adult men and women aged 18 to 75 years with distal mild to moderate onychomycosis due
to dermatophyte fungi (i.e. involving > or = 20% to < or = 60% of the distal bed adherent nail plate,
without involvement of the lunula) affecting at least one big toenail.
3. Disease proven by culture at screening (positivity confirmed before randomization).
4. Positive Dermatophyte Test Strip (DTS) at screening (positivity confirmed before randomization). In case of negative DTS result, the test can be repeated within 2 weeks. Only when there is a positive result of DTS, the sample will be sent to the central lab for culture.
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 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Allergy to ciclopirox or to any component of the study medication.
2. Life expectancy less than 2 years at screening.
3. Regular use of cosmetic lacquer on the toenails, unwilling to interrupt.
4. Pregnancy or breast-feeding.
5. Woman of child bearing potential who does not use any reliable contraception.
6. Systemic antifungal drugs in the 6 months prior to screening, or need for same.
7. Topical antifungal drugs in the four weeks prior to screening visit.
8. Chemotherapy in the 12 weeks prior to screening or need for same.
9. Immunosuppressive therapy in the 12 weeks prior to screening or need for same.
10. Systemic glucocorticosteroids in the 4 weeks prior to screening or need for same.
11. Systemic antimetabolites in the 4 weeks prior to screening or need for same.
12. Systemic immunostimulants in the 4 weeks prior to screening or need for same.
13. Evidence of psoriasis.
14. Uncontrolled diabetes mellitus (irrespective IDDM, NIDDM).
15. Suspicion or evidence of severe liver or kidney disease.
16. Alcohol or substance abuse.
17. AIDS or any other immunodeficiency.
18. Onychomycosis caused by yeasts or non-dermatophytes moulds.
19. Mucocutaneous candidiasis.
20. White superficial onychomycosis.
21. Proximal subungual involvement (marker of immunosuppressed patient).
22. Yellow spikes” on nail (extension of fungal infection from distal to proximal part of nail).
23. Patients with recurrent erysipela at the screening (if erysipela infection occur during the study,
the patient will be allowed to continue the study and to be treated with antibiotic (penicillin)).
24. Any other medical condition which, in the investigator’s opinion, contraindicates the subject’s
participation in the trial.
25. Forecast of little cooperation, non-compliance of medical treatment or little credibility.
26. Has participated in any clinical investigation with medicine within the last 6 months prior to
screening visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials