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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01433107
First received: September 8, 2011
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Tinea Pedis
Drug: Terbinafine
Drug: Terbinafine Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) [ Time Frame: week 6 ] [ Designated as safety issue: No ]

    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:
  • Total Clinical Signs and Symptoms (S/S) Scores [ Time Frame: week 6 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Number of Subjects with adverse event


Enrollment: 290
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Terbinafine
Drug
Drug: Terbinafine
1% single application
Placebo Comparator: Placebo
Drug
Drug: Terbinafine Placebo
single application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433107

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01433107     History of Changes
Other Study ID Numbers: 727-D-301
Study First Received: September 8, 2011
Results First Received: April 8, 2013
Last Updated: December 3, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Tinea pedis
Terbinafine film forming solution

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Terbinafine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014