Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

This study has been completed.

Study NCT00443898 Information provided by Novartis

First Received on March 5, 2007. Last Updated on April 26, 2011 History of Changes

Results First Received: January 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Onychomycosis
Interventions:	Drug: terbinafine Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Terbinafine 24 w	Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Vehicle 24 w	vehicle (placebo) applied once daily for 24 weeks
Terbinafine 48 w	Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Vehicle 48 w	vehicle (placebo) applied once daily for 48 weeks

Participant Flow: Overall Study

	Terbinafine 24 w	Vehicle 24 w	Terbinafine 48 w	Vehicle 48 w
STARTED	126	128	136	128
COMPLETED	102	103	107	110
NOT COMPLETED	24	25	29	18
Adverse Event	0	0	1	1
Lack of Efficacy	2	3	3	1
Protocol Violation	1	1	1	0
Withdrawal by Subject	11	10	10	6
Lost to Follow-up	10	10	14	10
Death	0	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Terbinafine 24 w	Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Vehicle 24 w	vehicle (placebo) applied once daily for 24 weeks
Terbinafine 48 w	Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Vehicle 48 w	vehicle (placebo) applied once daily for 48 weeks

Baseline Measures

	Terbinafine 24 w	Vehicle 24 w	Terbinafine 48 w	Vehicle 48 w	Total
Number of Participants [units: participants]	126	128	136	128	518
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	107	101	116	100	424
>=65 years	19	27	20	28	94
Gender [units: participants]
Female	25	29	26	27	107
Male	101	99	110	101	411

Outcome Measures

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1. Primary:

Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. [ Time Frame: 52 weeks ]

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2. Secondary:

Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. [ Time Frame: 52 weeks ]

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3. Secondary:

Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. [ Time Frame: 52 weeks ]

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4. Secondary:

Number of Participants Assessed With Adverse Events and Serious Adverse Events [ Time Frame: 52 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00443898 History of Changes
Other Study ID Numbers:	CSFO327N2301
Study First Received:	March 5, 2007
Results First Received:	January 19, 2011
Last Updated:	April 26, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Iceland: Ministry of Health and Social Security