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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Terbinafine
* Drug: Terbinafine Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terbinafine<br>Drug | Drug: Terbinafine<br>* 1% single application<br>|
| Placebo Comparator: Placebo<br>Drug | Drug: Terbinafine Placebo<br>* single application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 = mild = moderate = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18 | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 = mild = moderate = severe In order to calculate the total symptom score, the scores for each individual symptom are added up. Possible range : 0 to 18 | week 6 | 
| Number of Subjects With Adverse Event | Number of Subjects with adverse event | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinea pedis, Terbinafine film forming solution