Doppelblinde, randomisierte klinische Studie zum Vergleich der Wirksamkeit und Verträglichkeit von Terbinafin Creme 1% vs. Lamisil® Creme vs. Grundlagebei Patienten mit Tinea pedis - 08-01 / Ter-C

Phase 1

• Conditions: Tinea pedis; MedDRA version: 9.1Level: LLTClassification code 10043873Term: Tinea pedis

• Registration Number: EUCTR2008-004695-49-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-30
• Study Completion: 2010-04-16
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

males and females of at least 18 years of age
written informed consent after being verbally informed by the investigator
diagnosis of Tinea pedis interdigitalis confirmed by a positive microscopical native preparation with 30% caustic potash
at least moderate severity of skin infection, i.e. patients must have score value of at least 4 (=sum score of the clinical parameters pruritus, erythema, desquamation, exudation, blisters and pustules, each rated on a scale of 0 to 3)
Women of childbearing potential: Use of a highly effective contraception method for the duration of the study
Women of childbearing potential: Negative pregnancy test prior to treatment start
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

topical treatment with antimycotic preparations in the test area during the 7 days prior to study inclusion
systemic treatment with antimycotic preparations during the 4 weeks prior to study inclusion
known intolerance of or hypersensitivity to terbinafine or any other ingredient of the study medication
severe heart failure or circulatory failure, severy hepatic or renal insufficiency, severe respiratory insufficiency, neoplasm
severe acute or chronic concomitant disease seriously affecting the general condition
concomitant diseases which may -taking the present knowledge into account- influence the parameters assessed in the study in a way that would make an objective evaluation impossible
concomitant medication which may -taking the present knowledge into account- influence the methods of measurement used in this study or the resulting data
well-founded doubt regarding the cooperation of the patient
dementia or any other severe intellectual impairment which makes a sound assessment of the patient history or a sound self-assessment impossible
excessive consumption of alcohol, illegal drugs, medicaments or nicotine
participation in another clinical trial within 30 days prior to inclusion or during this study
former participation in this clinical trial
pregnancy, lactation

Study & Design

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