Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merz Pharmaceuticals, LLC

ClinicalTrials.gov Identifier:

NCT00750139

First received: September 8, 2008

Last updated: April 19, 2013

Last verified: April 2013

History of Changes

Results First Received: February 13, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Tinea Pedis Athlete's Foot
Interventions:	Drug: NAFT-500 Drug: Placebo 2-weeks Drug: Naftin 1% Drug: Placebo 4-weeks

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
NAFT-500	Naftin 2% Cream applied daily for 2 weeks
Placebo 2-wks	Placebo applied daily for 2-weeks
Naftin 1%	Naftin 1% active comparator applied daily for 4 weeks
Placebo 4-wks	Placebo cream applied daily for 4 weeks

Participant Flow: Overall Study

	NAFT-500	Placebo 2-wks	Naftin 1%	Placebo 4-wks
STARTED	234	118	236	119
COMPLETED	145	59	135	73
NOT COMPLETED	89	59	101	46
Adverse Event	1	2	0	1
Lost to Follow-up	17	12	15	6
Withdrawal by Subject	3	2	6	2
Physician Decision	1	1	0	0
Non-compliance	1	0	1	3
Termination by sponsor	4	0	0	1
Non-specific	62	42	79	33

Baseline Characteristics

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Reporting Groups

	Description
NAFT-500	Naftin 2% Cream applied daily for 2 weeks
Placebo 2-wks	Placebo applied daily for 2-weeks
Naftin 1%	Naftin 1% active comparator applied daily for 4 weeks
Placebo 4-wks	Placebo cream applied daily for 4 weeks
Total	Total of all reporting groups

Baseline Measures

	NAFT-500	Placebo 2-wks	Naftin 1%	Placebo 4-wks	Total
Number of Participants [units: participants]	234	118	236	119	707
Age [units: participants]
<=18 years	2	1	14	6	23
Between 18 and 65 years	220	115	212	111	658
>=65 years	12	2	10	2	26
Age [units: years] Mean ± Standard Deviation	42.7 ± 13.03	41.0 ± 12.91	41.4 ± 14.08	41.4 ± 14.00	41.7 ± 13.52
Gender [units: participants]
Female	63	38	71	33	205
Male	171	80	165	86	502
Region of Enrollment [units: participants]
United States	234	118	236	119	707

Outcome Measures

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1. Primary:

Percentage of Subjects With Complete Cure at Week 6. [ Time Frame: Week 6 ]

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2. Secondary:

Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 [ Time Frame: Week 6 ]

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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: Institution and Principal Investigator agree not to individually publish the results of the Study. Institution and Principal Investigator may, however, upon written notice to Merz participate in a joint, multicenter publication of the Study results with other investigators and/or institutions, provided that the manuscript or abstract is first reviewed by Merz.

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: Associate Medical Director- Dermatology
Organization: Merz Pharmaceuticals, LLC
phone: 800-334-0514

No publications provided

Responsible Party:	Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00750139 History of Changes
Other Study ID Numbers:	MUS 90200-0736/1
Study First Received:	September 8, 2008
Results First Received:	February 13, 2012
Last Updated:	April 19, 2013
Health Authority:	United States: Food and Drug Administration

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