Double blind, comparative, randomized, placebo controlled, clinical study of therapeutic equivalence and tolerability of the topical preparation Terbinafine cream 1% (Pliva Croatia) with the medical preparation Lamisil (terbinafine 1% cream), for patients affected from uncomplicated Tinea pedis (Athlete´s Foot).

• Conditions: ncomplicated Tinea pedis.

• Registration Number: EUCTR2006-000775-15-CZ
• Lead Sponsor: PLIVA - ISTRAŽIVANJE I RAZVOJ d.o.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 770

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified