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Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis

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ClinicalTrials.gov Identifier: NCT01353976
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : January 9, 2013
Last Update Posted : January 9, 2013
Sponsor:
Collaborator:
AmDerma Pharmaceuticals, LLC
Information provided by (Responsible Party):
AmDerma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Tinea Pedis
Athlete's Foot
Interventions Drug: Econazole Nitrate Foam 1%
Other: Vehicle Foam
Enrollment 264
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Econazole Nitrate Foam 1% Vehicle Foam
Hide Arm/Group Description Study medication Placebo medication
Period Title: Overall Study
Started 130 134
Completed 82 83
Not Completed 48 51
Arm/Group Title Econazole Nitrate Foam 1% Vehicle Foam Total
Hide Arm/Group Description Study medication Placebo medication Total of all reporting groups
Overall Number of Baseline Participants 130 134 264
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 134 participants 264 participants
<=18 years
4
   3.1%
3
   2.2%
7
   2.7%
Between 18 and 65 years
121
  93.1%
125
  93.3%
246
  93.2%
>=65 years
5
   3.8%
6
   4.5%
11
   4.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 134 participants 264 participants
41.7  (12.48) 42.5  (12.85) 42.1  (12.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 134 participants 264 participants
Female
45
  34.6%
56
  41.8%
101
  38.3%
Male
85
  65.4%
78
  58.2%
163
  61.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 134 participants 264 participants
United States 91 92 183
Dominican Republic 39 42 81
1.Primary Outcome
Title Complete Cure
Hide Description Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title Econazole Nitrate Foam 1% Vehicle Foam
Hide Arm/Group Description:
Study medication
Placebo medication
Overall Number of Participants Analyzed 82 83
Measure Type: Number
Unit of Measure: Participants
No 63 81
Yes 19 2
2.Secondary Outcome
Title Effective Treatment
Hide Description Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title Econazole Nitrate Foam 1% Vehicle Foam
Hide Arm/Group Description:
Study medication
Placebo medication
Overall Number of Participants Analyzed 82 83
Measure Type: Number
Unit of Measure: Participants
No 42 74
Yes 40 9
3.Secondary Outcome
Title Mycological Cure
Hide Description Mycological Cure defined as negative KOH and negative culture at Day 43.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title Econazole Nitrate Foam 1% Vehicle Foam
Hide Arm/Group Description:
Study medication
Placebo medication
Overall Number of Participants Analyzed 82 83
Measure Type: Number
Unit of Measure: Participants
No 26 70
Yes 56 13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Econazole Nitrate Foam 1% Vehicle Foam
Hide Arm/Group Description Study medication Placebo medication
All-Cause Mortality
Econazole Nitrate Foam 1% Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Econazole Nitrate Foam 1% Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/130 (0.00%)      1/134 (0.75%)    
Vascular disorders     
Hypertension  0/130 (0.00%)  0 1/134 (0.75%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Econazole Nitrate Foam 1% Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/130 (13.08%)      16/134 (11.94%)    
Gastrointestinal disorders     
Oral Pain  1/130 (0.77%)  1 0/134 (0.00%)  0
General disorders     
Application Site Dermatitis  0/130 (0.00%)  0 1/134 (0.75%)  1
Infections and infestations     
Cystitis  1/130 (0.77%)  1 0/134 (0.00%)  0
Helicobacter gastritis  1/130 (0.77%)  1 0/134 (0.00%)  0
Influenza  1/130 (0.77%)  1 0/134 (0.00%)  0
Nasopharyngitis  2/130 (1.54%)  2 4/134 (2.99%)  4
Sinusitis Bacterial  0/130 (0.00%)  0 1/134 (0.75%)  1
Upper Respiratory Tract Infection  1/130 (0.77%)  1 1/134 (0.75%)  1
Injury, poisoning and procedural complications     
Ligament Injury  1/130 (0.77%)  1 0/134 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1/130 (0.77%)  1 0/134 (0.00%)  0
Nervous system disorders     
Headache  6/130 (4.62%)  6 6/134 (4.48%)  6
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  1/130 (0.77%)  1 0/134 (0.00%)  0
Nasal Dryness  0/130 (0.00%)  0 1/134 (0.75%)  1
Oropharyngeal Pain  1/130 (0.77%)  1 0/134 (0.00%)  0
Pulmonary Congestion  0/130 (0.00%)  0 1/134 (0.75%)  1
Rhinorrhea  0/130 (0.00%)  0 1/134 (0.75%)  1
Vascular disorders     
Hypertension  0/130 (0.00%)  0 1/134 (0.75%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Candis Edwards
Organization: AmDerma Pharmaceuticals
Phone: 631-974-7949
EMail: cedwards@amderma.com
Layout table for additonal information
Responsible Party: AmDerma
ClinicalTrials.gov Identifier: NCT01353976     History of Changes
Other Study ID Numbers: 079-2951-302
First Submitted: May 12, 2011
First Posted: May 16, 2011
Results First Submitted: December 5, 2012
Results First Posted: January 9, 2013
Last Update Posted: January 9, 2013