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: March 14, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2011
Last Updated Date	March 14, 2012
Start Date ^ICMJE	August 2011
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2011)	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 = mild = moderate = severe
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01433107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2011)	Individual and 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 = mild = moderate = severe Number of Subjects with adverse event [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ] Number of Subjects with adverse event
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Tinea Pedis
Intervention ^ICMJE	Drug: Terbinafine 1% single application Drug: Terbinafine Placebo single application
Study Arm (s)	Experimental: Terbinafine Drug Intervention: Drug: Terbinafine Placebo Comparator: Placebo Drug Intervention: Drug: Terbinafine Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	290
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01433107
Other Study ID Numbers ^ICMJE	727-D-301
Has Data Monitoring Committee	No
Responsible Party	Novartis
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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