Trial Outcomes & Findings for Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis (NCT NCT01353976)
NCT ID: NCT01353976
Last Updated: 2013-01-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
264 participants
Primary outcome timeframe
Day 43
Results posted on
2013-01-09
Participant Flow
Participant milestones
| Measure |
Econazole Nitrate Foam 1%
Study medication
|
Vehicle Foam
Placebo medication
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
134
|
|
Overall Study
COMPLETED
|
82
|
83
|
|
Overall Study
NOT COMPLETED
|
48
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis
Baseline characteristics by cohort
| Measure |
Econazole Nitrate Foam 1%
n=130 Participants
Study medication
|
Vehicle Foam
n=134 Participants
Placebo medication
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
121 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
41.7 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 12.85 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
92 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 43Population: MITT
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.
Outcome measures
| Measure |
Econazole Nitrate Foam 1%
n=82 Participants
Study medication
|
Vehicle Foam
n=83 Participants
Placebo medication
|
|---|---|---|
|
Complete Cure
No
|
63 Participants
|
81 Participants
|
|
Complete Cure
Yes
|
19 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 43Population: MITT
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.
Outcome measures
| Measure |
Econazole Nitrate Foam 1%
n=82 Participants
Study medication
|
Vehicle Foam
n=83 Participants
Placebo medication
|
|---|---|---|
|
Effective Treatment
No
|
42 Participants
|
74 Participants
|
|
Effective Treatment
Yes
|
40 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 43Population: MITT
Mycological Cure defined as negative KOH and negative culture at Day 43.
Outcome measures
| Measure |
Econazole Nitrate Foam 1%
n=82 Participants
Study medication
|
Vehicle Foam
n=83 Participants
Placebo medication
|
|---|---|---|
|
Mycological Cure
No
|
26 Participants
|
70 Participants
|
|
Mycological Cure
Yes
|
56 Participants
|
13 Participants
|
Adverse Events
Econazole Nitrate Foam 1%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Vehicle Foam
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Econazole Nitrate Foam 1%
n=130 participants at risk
Study medication
|
Vehicle Foam
n=134 participants at risk
Placebo medication
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/130
|
0.75%
1/134 • Number of events 1
|
Other adverse events
| Measure |
Econazole Nitrate Foam 1%
n=130 participants at risk
Study medication
|
Vehicle Foam
n=134 participants at risk
Placebo medication
|
|---|---|---|
|
Gastrointestinal disorders
Oral Pain
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
General disorders
Application Site Dermatitis
|
0.00%
0/130
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
Infections and infestations
Helicobacter gastritis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
Infections and infestations
Influenza
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
2/130 • Number of events 2
|
3.0%
4/134 • Number of events 4
|
|
Infections and infestations
Sinusitis Bacterial
|
0.00%
0/130
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.77%
1/130 • Number of events 1
|
0.75%
1/134 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
Nervous system disorders
Headache
|
4.6%
6/130 • Number of events 6
|
4.5%
6/134 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/130
|
0.75%
1/134 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.77%
1/130 • Number of events 1
|
0.00%
0/134
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/130
|
0.75%
1/134 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/130
|
0.75%
1/134 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/130
|
0.75%
1/134 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place