Uncomplicated Tinea pedis.
Conditions
Interventions
Product Name: Terbinafine cream 1%
Pharmaceutical Form: Cream
INN or Proposed INN: terbinafine hydrochloride
CAS Number: 78628-80-5
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Sponsors
PLIVA - ISTRAŽIVANJE I RAZVOJ d.o.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged between 18-70 years. 2.Local finding of uncomplicated Tinea pedis (Athlete´s Foot) confirmed by a microscopy. 3.Informed Consent Form, voluntarily signed after being fully informed. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with concomitantly treated onychomycosis. 2. Patients with onychomycosis on the evaluated foot. 3. Patients with plantar mycosis, vesicle-pustular or hyperkeratosquamous. 4. Patients concomitantly treated with radiotherapy, systemic chemotherapy or immunosuppression, or patients with such treatment terminated less than two months before being included in the study. 5. Patients treated with local antimycotics at any place within the body, within 4 weeks before being included in the study, or with systemic antimycotic therapy within 12 weeks before being included in the study. 6. Patients treated with local corticosteroids at the area affected by uncomplicated Tinea pedis within 4 weeks before being included in the study, or with systemic corticosteroid therapy within 12 weeks before being included in the study. 7. Patients treated with antihistaminics 30 days before being included in the study. 8. Patients with acquired immunodeficiency syndrome (HIV infection). 9. Pregnant or breast-feeding female. 10. Women of childbearing potential without adequate contraception (barrier, hormonal). 11. Patients allergic to any of the substances to be administered during the study. 12. Patients unable to cooperate. 13. Patients taking part in another study within the past 4 weeks and during this study. 14. Patients addicted to alcohol or drugs. 15. Patients unwilling to sign an informed consent form. 16. Patients with active tuberculosis, known thyroid hyperfunction, diabetes mellitus treated with oral antidiabetics and/or insulin. 17. Vulnerable subjects (e.g. soldiers in military service, people depending on the investigator – e.g. subordinates, members of family).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of therapeutic equivalence of the generic topical preparation Terbinafine cream 1% (Pliva Croatia) with the medical preparation Lamisil (terbinafine 1% cream) for patients with uncomplicated Tinea pedis (Athlete´s Foot).;Secondary Objective: Superiority testing against placebo. Assessment of tolerability.;Primary end point(s): Negative mycology culture at visit 3. | — |
Countries
Czech Republic
Outcome results
None listed