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

December 3, 2013 updated by: Novartis

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

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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100083
        • Beijing University Hospital N°3
      • Guangdong, China, 510120
        • The Second Affiliated Hospital of Sun Yat-sen University Guangzhou
      • Guangzhou, China, 510630
        • The Third Affiliated Hospital of Sun Yat-sen University
      • Jiangsu, China, 21004
        • Chinese Academy of Medical Sciences
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug
single application
Experimental: Terbinafine
Drug
1% single application

What is the study measuring?

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)
Time Frame: 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

week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Clinical Signs and Symptoms (S/S) Scores
Time Frame: 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

week 6
Number of Subjects With Adverse Event
Time Frame: 6 weeks
Number of Subjects with adverse event
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (Estimate)

September 13, 2011

Study Record Updates

Last Update Posted (Estimate)

December 27, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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