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

Tinea Pedis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433107
• Other study ID #: 727-D-301
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2011
• Last updated: December 3, 2013
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Terbinafine
1% single application
• Terbinafine Placebo
single application

Locations

Country	Name	City	State
China	Beijing University Hospital N°3	Beijing
China	Peking University First Hospital	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	Chinese Academy of Medical Sciences	Jiangsu
China	Huashan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of Subjects With Adverse Event	Number of Subjects with adverse event	6 weeks	Yes