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

Phase 3

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Terbinafine; Drug: Terbinafine Placebo

• Registration Number: NCT01433107
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2013-04-08
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Results First Posted: 2013-12-27
• Last Update Posted: 2013-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terbinafine	Terbinafine	Drug
Placebo	Terbinafine Placebo	Drug

Primary Outcome Measures

Name	Time	Method
Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)	week 6	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

Secondary Outcome Measures

Name	Time	Method
Total Clinical Signs and Symptoms (S/S) Scores	week 6	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
Number of Subjects With Adverse Event	6 weeks	Number of Subjects with adverse event

Trial Locations

Locations (6)

The Second Affiliated Hospital of Sun Yat-sen University Guangzhou; 🇨🇳 Guangdong, China

Chinese Academy of Medical Sciences; 🇨🇳 Jiangsu, China

Beijing University Hospital N°3; 🇨🇳 Beijing, China

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, China

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, China

Peking University First Hospital; 🇨🇳 Beijing, China