toenail onychomycosis MedDRA version: 19.1 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: RJ-0265
Product Code: RJ-0265
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: CICLOPIROX
CAS Number: 29342-05-0
Sponsors
Laboratorio Reig Jofre, SA
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of RJ-0265, in terms of complete cure, compared to placebo, for the treatment of toenail onychomycosis due to dermatophyte fungi.; Secondary Objective: - To evaluate the efficacy of RJ-0265, in terms of clinical success, responder and improvement, in comparison with placebo at week 52. - To evaluate the efficacy of RJ-0265, in terms of complete cure, in comparison with the marketed reference ciclopirox nail lacquer at week 52. -To evaluate the efficacy of RJ-0265, in terms of clinical success, responder and improvement, compared to marketed reference ciclopirox nail lacquer at week 52. -To assess the growth rate of healthy nail, at week 52. -To assess the time (months) to complete cure or clinical success, at week 52. -To assess all efficacy endpoints at week 48 (end of treatment). -To evaluate the efficacy of RJ-0265, in terms of complete cure, Clinical success and Responders in comparison with placebo at week 52 depending on the baseline degree of involvement Overall safety of 48 weeks of treatment and follow-up ;Primary end point(s): Rate of complete cure, assessed by an independent evaluator, at week 52 (comparison between RJ-0265 and placebo).;Timepoint(s) of evaluation of this end point: At week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At week 52; Secondary end point(s): - Rate of clinical success as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo) - Rate of responders as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo). - Rate of improvement, as assessed by the independent evaluator, at the end of treatment versus baseline and conversion to negative KOH and culture (comparison between RJ-0265 and placebo). - Decrease of diseased nail area to =10% of total, as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo). - Conversion to negative of culture at week 52 (comparison between RJ-0265 and placebo). - Conversion to negative of microscopy findings on KOH examination at week 52 (comparison between RJ-0265 and placebo). - Preliminary assessment of clinical cure, clinical success and responder rate by investigators at week 52. - Growth rate of healthy nail, at week 52. - Diseased nail area by computer planimetry evaluation, after confirmation of independent evaluator (comparison between RJ-0265 and placebo). - Time (months) to complete cure or clinical success as assessed by the independent evaluator and by the investigator. - Rate of complete cure, clinical success and Responders as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo) depending on the baseline degree of involvement (e.g. <30%, <50%, etc.) | — |
Countries
Latvia, Mexico, Spain
Contacts
Public ContactClinical R&D
Laboratorio Reig Jofre, SA
Outcome results
None listed