EUCTR2016-003784-19-ES
Active, not recruiting
Phase 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 enrollmentApril 18, 2017
DrugsOny-Tec
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- aboratorio Reig Jofre, SA
- Enrollment
- 360
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent before starting any study related procedures.
- •2\. Adult men and women aged 18 to 70 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 KOH preparation at screening (positivity confirmed before randomization).
- •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
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.
Outcomes
Primary Outcomes
Not specified
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