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

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Terbinafine
Terbinafine Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis focused on measuring Tinea pedis, Terbinafine film forming solution

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First Hospital
  • Beijing University Hospital N°3
  • The Second Affiliated Hospital of Sun Yat-sen University Guangzhou
  • The Third Affiliated Hospital of Sun Yat-sen University
  • Chinese Academy of Medical Sciences
  • Huashan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Terbinafine

Placebo

Arm Description

Drug

Drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number of Subjects With Adverse Event
Number of Subjects with adverse event

Full Information

First Posted
September 8, 2011
Last Updated
December 3, 2013
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01433107
Brief Title
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
Tinea pedis, Terbinafine film forming solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Terbinafine
Arm Type
Experimental
Arm Description
Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
Terbinafine
Intervention Description
1% single application
Intervention Type
Drug
Intervention Name(s)
Terbinafine Placebo
Intervention Description
single application
Primary Outcome Measure Information:
Title
Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
Description
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
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Total Clinical Signs and Symptoms (S/S) Scores
Description
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
Time Frame
week 6
Title
Number of Subjects With Adverse Event
Description
Number of Subjects with adverse event
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing University Hospital N°3
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
The Second Affiliated Hospital of Sun Yat-sen University Guangzhou
City
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Chinese Academy of Medical Sciences
City
Jiangsu
ZIP/Postal Code
21004
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

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

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