EUCTR2016-003784-19-LVActive, not recruitingPhase 1
Phase III, multicentre, randomised, double blind, parallel-group, clinical trial to evaluate the efficacy and safety of a new medicated nail lacquer for the treatment of toenail fungal infection
aboratorio Reig Jofre, SA0 sites360 target enrollmentStarted: June 20, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 360
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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.
Investigators
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