Trial Outcomes & Findings for A Study of Econazole Foam 1% in Athlete's Foot (NCT NCT00768599)
NCT ID: NCT00768599
Last Updated: 2013-01-09
Results Overview
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Day 43
Results posted on
2013-01-09
Participant Flow
One-hundred and ninety-eight (198) subjects were screened and 135 were enrolled/randomized in the study. Subjects with negative KOH evaluations in both regions (all scrapings negative) were considered Screen Failures and were not enrolled into the study. Subject enrollment and completion dates are March 27, 2008 - September 25, 2008.
Subjects who met the inclusion/exclusion criteria were randomized to receive Econazole Nitrate Foam 1%, Econazole Nitrate Cream 1%, or Foam vehicle in a 1:1:1 ratio.
Participant milestones
| Measure |
Reference Drug
Econazole Nitrate Cream 1%
|
Test Drug
Econazole Nitrate Foam 1%
|
Control
Vehicle Foam
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
47
|
|
Overall Study
COMPLETED
|
34
|
27
|
35
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Econazole Foam 1% in Athlete's Foot
Baseline characteristics by cohort
| Measure |
Reference Drug
n=45 Participants
Econazole Nitrate Cream 1%
|
Test Drug
n=43 Participants
Econazole Nitrate Foam 1%
|
Control
n=47 Participants
Vehicle Foam
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age Continuous
|
45.4 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
43 participants
n=7 Participants
|
47 participants
n=5 Participants
|
135 participants
n=4 Participants
|
|
Weight
|
194.4 lbs
STANDARD_DEVIATION 45.49 • n=5 Participants
|
199.5 lbs
STANDARD_DEVIATION 56.06 • n=7 Participants
|
207.0 lbs
STANDARD_DEVIATION 49.75 • n=5 Participants
|
200.4 lbs
STANDARD_DEVIATION 50.42 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 43Population: MITT
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Outcome measures
| Measure |
Reference Drug
n=32 Participants
Econazole Nitrate Cream 1%
|
Test Drug
n=27 Participants
Econazole Nitrate Foam 1%
|
Control
n=28 Participants
Vehicle Foam
|
|---|---|---|---|
|
Complete Cure Rate: Interdigital Disease
|
9 Participants
|
9 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 43 DaysPopulation: MITT
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Outcome measures
| Measure |
Reference Drug
n=10 Participants
Econazole Nitrate Cream 1%
|
Test Drug
n=10 Participants
Econazole Nitrate Foam 1%
|
Control
n=19 Participants
Vehicle Foam
|
|---|---|---|---|
|
Complete Cure Rate: Moccasin Disease
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 43Population: MITT
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 (Week6).
Outcome measures
| Measure |
Reference Drug
n=32 Participants
Econazole Nitrate Cream 1%
|
Test Drug
n=27 Participants
Econazole Nitrate Foam 1%
|
Control
n=28 Participants
Vehicle Foam
|
|---|---|---|---|
|
Effective Treatment: Interdigital Disease
|
21 Participants
|
16 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 43Population: MITT
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 (Week6).
Outcome measures
| Measure |
Reference Drug
n=10 Participants
Econazole Nitrate Cream 1%
|
Test Drug
n=10 Participants
Econazole Nitrate Foam 1%
|
Control
n=19 Participants
Vehicle Foam
|
|---|---|---|---|
|
Effective Treatment: Mocassin Disease
|
3 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 43Population: MITT
Negative KOH and negative fungal culture at Day 43
Outcome measures
| Measure |
Reference Drug
n=32 Participants
Econazole Nitrate Cream 1%
|
Test Drug
n=27 Participants
Econazole Nitrate Foam 1%
|
Control
n=28 Participants
Vehicle Foam
|
|---|---|---|---|
|
Mycological Cure: Interdigital Disease
|
27 Participants
|
20 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 43Population: MITT
Negative KOH and negative fungal culture at Day 43
Outcome measures
| Measure |
Reference Drug
n=10 Participants
Econazole Nitrate Cream 1%
|
Test Drug
n=10 Participants
Econazole Nitrate Foam 1%
|
Control
n=19 Participants
Vehicle Foam
|
|---|---|---|---|
|
Mycological Cure: Mocassin Disease
|
5 Participants
|
5 Participants
|
1 Participants
|
Adverse Events
Reference Drug
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Test Drug
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference Drug
n=45 participants at risk
Econazole Nitrate Cream 1%
|
Test Drug
n=43 participants at risk
Econazole Nitrate Foam 1%
|
Control
n=47 participants at risk
Vehicle Foam
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Gastrointestinal disorders
Tooth Abcess
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
General disorders
Pain
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
General disorders
Swelling
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Hepatobiliary disorders
Hepatitis C
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Immune system disorders
Seasonal Allergy
|
2.2%
1/45 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
2.1%
1/47 • Number of events 1
|
|
Infections and infestations
Viral Infection
|
0.00%
0/45
|
0.00%
0/43
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anthropod Sting
|
0.00%
0/45
|
0.00%
0/43
|
2.1%
1/47 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/45
|
7.0%
3/43 • Number of events 3
|
0.00%
0/47
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Investigations
Glucose Urine Present
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/45
|
0.00%
0/43
|
2.1%
1/47 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Renal and urinary disorders
Pyuria
|
2.2%
1/45 • Number of events 1
|
0.00%
0/43
|
0.00%
0/47
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
0.00%
0/45
|
0.00%
0/43
|
2.1%
1/47 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45
|
2.3%
1/43 • Number of events 1
|
0.00%
0/47
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/45
|
0.00%
0/43
|
2.1%
1/47 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Stasis Dermatitis
|
0.00%
0/45
|
0.00%
0/43
|
2.1%
1/47 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER