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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01433107
• Collaborator: (none)
• Enrollment: 290
• Locations: 6
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 48.3
• Patients Per Site Per Month: 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: Terbinafine; Drug: Terbinafine Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) [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 = 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

1. Total Clinical Signs and Symptoms (S/S) Scores [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 = 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

2. Number of Subjects With Adverse Event [6 weeks]

   Number of Subjects with adverse event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing		China	100034
2	Beijing University Hospital N°3	Beijing		China	100083
3	The Second Affiliated Hospital of Sun Yat-sen University Guangzhou	Guangdong		China	510120
4	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou		China	510630
5	Chinese Academy of Medical Sciences	Jiangsu		China	21004
6	Huashan Hospital, Fudan University	Shanghai		China	200040

Sponsors and Collaborators

• Novartis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT01433107
• Other Study ID Numbers: 727-D-301
• First Posted: Sep 13, 2011
• Last Update Posted: Dec 27, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Novartis: Tinea pedis; Terbinafine film forming solution
• Additional relevant MeSH terms: Tinea; Tinea Pedis; Terbinafine

Study Results

Participant Flow

Recruitment Details	Study start 27 Aug 2011 end 14 Feb 2012
Pre-assignment Detail	Each particiapant received a single dose of Terbinafine Film Forming Solution 1% or matching placebo

Arm/Group Title	Terbinafine	Placebo
Arm/Group Description	Drug	Drug
Period Title: Overall Study
STARTED	145	145
COMPLETED	118	128
NOT COMPLETED	27	17

Baseline Characteristics

Arm/Group Title	Terbinafine	Placebo	Total
Arm/Group Description	Drug	Drug	Total of all reporting groups
Overall Participants	145	145	290
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.27 (12.805)	34.05 (11.936)	34.66 (12.372)
Sex: Female, Male (Count of Participants)
Female	50 34.5%	46 31.7%	96 33.1%
Male	95 65.5%	99 68.3%	194 66.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).

Arm/Group Title	Terbinafine	Placebo
Arm/Group Description	Drug	Drug
Measure Participants	115	122
Number [participants]	73 50.3%	10 6.9%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Terbinafine	Placebo
Arm/Group Description	Drug	Drug
Measure Participants	113	121
Mean (95% Confidence Interval) [units on a scale]	1.6	4.7

3. Secondary Outcome

Title	Number of Subjects With Adverse Event
Description	Number of Subjects with adverse event
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.

Arm/Group Title	Terbinafine	Placebo
Arm/Group Description	Drug	Drug
Measure Participants	146	144
Number [participants]	9 6.2%	11 7.6%

Adverse Events

Adverse Event Reporting Description	One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.
Arm/Group Title	Terbinafine		Placebo
Arm/Group Description	Drug		Drug
All Cause Mortality
	Terbinafine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Terbinafine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/146 (0%)		0/144 (0%)
Other (Not Including Serious) Adverse Events
	Terbinafine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/146 (0%)		7/144 (4.9%)
General disorders
General Disorders	0/146 (0%)	0	7/144 (4.9%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Preliminary agreement between Novartis Consumer Health and the investigator