None listed
Conditions
Interventions
GROUP 1 Type of group
2 capsules, each with 175 mg of coated mini-tablets (for a total of 350 mg) QD for 2 weeks, followed by 2 weeks of rest (without drug). This cycle will be repeated for 3 cycles.
Group name:GROUP 3 Type of group
Identical placebo QD for 12 weeks.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Clinical diagnosis of subungual onychomycosis of the toenail confirmed by microscopy (KOH) and culture for dermatophyte. Patients must have an affected toenail with potential for growth confirmed of a minimum of 1 mm of. growth, during the 6-week screening period. The serum pregnancy test should be negative in female patients who may become pregnant and should use a medically approved method of contraception during the course of treatment and for 4 weeks after termination. Written informed consent must be obtained before participation in the study.
Exclusion criteria
Exclusion criteria: Patients who have received oral terbinafine within one year prior to screening for the study. Patients who have received terbinafine in cream within 3 months prior to screening for the study. Patients who have been treated with systemic antifungals (other than terbinafine) within six weeks prior to screening for the study or with antifungal topics (other than terbinafine) applied within two weeks prior to screening for the study. Patients with active psoriasis. Women who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Complete cure is defined as 0% of the residual commitment of the white toenail as documented by photographs, negative cultures for dermatophytes and negative KOH microscopy. Measure:Percentage of patients who experience a complete cure of the white toenail in week 48 Timepoints:48 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Clinical cure defined as 0% residual commitment of the white toenail. • Mycological cure defined as negative culture for dermatophytes and negative KOH microscopy. • Effective treatment defined as both 0% of residual commitment or at least 5 mm of growth of the unaffected toenail and negative culture for dermatophytes and negative KOH microscopy. • Clinical effectiveness defined as visual clearing of> 90% and / or <10% of the residual commitment of the white toenail and negative culture for dermatophytes. • Relapse defined as patients with complete cure before week 48 and who again have positive mycological culture, positive KOH microscopy or clinical evaluation. • General evaluation of the doctor and patient. • Quality of life. Measure:The percentage of patients that achieve a clinical cure, a mycological cure, effective treatment, clinical effectiveness, relapse, general evaluations of the doctor and patient and quality of life. Timepoints:48 week | — |
Countries
Peru
Outcome results
None listed