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Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis (NAFT-600)

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ClinicalTrials.gov Identifier: NCT01289015
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Tinea Pedis
Interventions Drug: NAFT-600 ( naftin 2 % gel )
Drug: Placebo
Enrollment 855
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NAFT-600 Placebo
Hide Arm/Group Description NAFT-600 : Topical; applied once daily for two weeks Placebo : Topical; applied once daily for two weeks
Period Title: Overall Study
Started 571 284
Completed 472 230
Not Completed 99 54
Reason Not Completed
Protocol Violation             12             9
Adverse Event             3             0
Lost to Follow-up             33             17
Withdrawal by Subject             17             8
Disease progression             1             0
Negative baseline culture and others             33             20
Arm/Group Title NAFT-600 Placebo Total
Hide Arm/Group Description NAFT-600 : Topical; applied once daily for two weeks Placebo : Topical; applied once daily for two weeks Total of all reporting groups
Overall Number of Baseline Participants 571 284 855
Hide Baseline Analysis Population Description
The Safety Evaluation Set (SES) which is the population of subjects who received at least one dose of study medication was used.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 571 participants 284 participants 855 participants
<=18 years
5
   0.9%
2
   0.7%
7
   0.8%
Between 18 and 65 years
524
  91.8%
255
  89.8%
779
  91.1%
>=65 years
42
   7.4%
27
   9.5%
69
   8.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 571 participants 284 participants 855 participants
45.3  (13.3) 46.4  (14.3) 45.7  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 571 participants 284 participants 855 participants
Female
416
  72.9%
221
  77.8%
637
  74.5%
Male
155
  27.1%
63
  22.2%
218
  25.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 571 participants 284 participants 855 participants
United States 545 271 816
Puerto Rico 26 13 39
1.Primary Outcome
Title Complete Cure of Interdigital Tinea Pedis
Hide Description

The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.

Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.

Time Frame Visit 4/ Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because culture results were not available before the start of treatment.
Arm/Group Title NAFT-600 Placebo
Hide Arm/Group Description:
NAFT-600 : Topical; applied once daily for two weeks
Placebo : Topical; applied once daily for two weeks
Overall Number of Participants Analyzed 382 179
Measure Type: Number
Unit of Measure: percentage of subjects
16.8 1.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NAFT-600, Placebo
Comments

In order to compare complete cure rate in the NAFT-600 group with that of the placebo group, the following one-sided hypothesis test was carried out:

H0 (null): p1<=p0 versus Ha (alternate): p1>p0, where p0 and p1 are the proportions of subjects with complete cure in the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments The CMH test statistic after stratification was used to compare subjects with complete cure between NAFT-600 and placebo.
Method of Estimation Estimation Parameter p-value
Estimated Value 0.001
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
Hide Description

Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).

Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.

Time Frame Visit 4/ Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) using a Modified Intent to Treat population.
Arm/Group Title NAFT-600 Placebo
Hide Arm/Group Description:
NAFT-600 : Topical; applied once daily for two weeks
Placebo : Topical; applied once daily for two weeks
Overall Number of Participants Analyzed 382 179
Measure Type: Number
Unit of Measure: percentage of subjects
Mycological Cure 65.4 14.0
Effective Treatment 54.2 6.1
Time Frame Adverse events were collected up to Week 6.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NAFT-600 Placebo
Hide Arm/Group Description NAFT-600 : Topical; applied once daily for two weeks Placebo : Topical; applied once daily for two weeks
All-Cause Mortality
NAFT-600 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NAFT-600 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/571 (0.35%)   2/284 (0.70%) 
Infections and infestations     
Abscess  1  0/571 (0.00%)  1/284 (0.35%) 
Respiratory Tract Infection  1  0/571 (0.00%)  1/284 (0.35%) 
Injury, poisoning and procedural complications     
Skull Fractured Base  1  1/571 (0.18%)  0/284 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle Spasms  1  1/571 (0.18%)  0/284 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
NAFT-600 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/571 (2.28%)   2/284 (0.70%) 
Nervous system disorders     
Headache  1  13/571 (2.28%)  2/284 (0.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Institution and Principal Investigator agreed not to individually publish or assist other person or entity with any articles, papers, and/or make presentations, speeches referring to the protocol, clinical trial data, the study, or the study drug or any data, results, materials, or information generated or obtained by the Institution or the Principal Investigator without the prior written consent of Merz, which consent may be withheld in the sole discretion of Merz.
Results Point of Contact
Name/Title: Stefan Plaum, MD Associate Medical Director
Organization: Merz Pharmaceuticals, LLC
Phone: 800-334-0514
Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01289015     History of Changes
Other Study ID Numbers: MRZ 90200/3015/1
First Submitted: January 28, 2011
First Posted: February 3, 2011
Results First Submitted: July 26, 2013
Results First Posted: September 26, 2013
Last Update Posted: September 26, 2013