Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

Novartis290 enrolled

Overview

This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

290

Conditions

Tinea Pedis

Interventions

TerbinafineDRUG

1% single application

Terbinafine PlaceboDRUG

single application

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy Exclusion Criteria: * Allergy to the allylamine class of antimycotics or excipients in the formulation. * Chronic, hyperkeratotic plantar (moccasin) tinea pedis * Other fungal disease or intertrigo * Other abnormal findings on the affected foot * Systemic antifungal or antimicrobial treatment within the last 3 months * Topical treatment for skin lesions on feet within the last 3 months * Diabetes mellitus and peripheral artery occlusive disease

Locations (6)

Peking University First Hospital

Beijing, China

Beijing University Hospital N°3

Beijing, China

The Second Affiliated Hospital of Sun Yat-sen University Guangzhou

Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Outcomes

Primary Outcomes

Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)

Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18

Time frame: week 6

Secondary Outcomes

Total Clinical Signs and Symptoms (S/S) Scores

Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptom score, the scores for each individual symptom are added up. Possible range : 0 to 18

Time frame: week 6

Number of Subjects With Adverse Event

Number of Subjects with adverse event

Time frame: 6 weeks

Data from ClinicalTrials.gov

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