Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis (NCT NCT01891305)
NCT ID: NCT01891305
Last Updated: 2018-08-01
Results Overview
For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-08-01
Participant Flow
Participant milestones
| Measure |
VT-1161 200/50mg
VT-1161 200mg once daily for 4 days, then VT-1161 50mg once daily for 10 days
|
VT-1161 600/150mg
VT-1161 600mg once daily for 4 days, then VT-1161 150mg once daily for 10 days
|
VT-1161 1200/300mg
VT-1161 1200mg once daily for 4 days, then VT-1161 300mg once daily for 10 days
|
Placebo
matching tablets over-encapsulated for blinding purposes
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
14
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
Baseline characteristics by cohort
| Measure |
VT-1161 200/50mg
n=12 Participants
|
VT-1161 600/150mg
n=12 Participants
|
VT-1161 1200/300mg
n=14 Participants
|
Matching Placebo
n=12 Participants
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 11.71 • n=7 Participants
|
34.05 years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 10.27 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 12.32 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksFor this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.
Outcome measures
| Measure |
VT-1161 200/50mg
n=12 Participants
|
VT-1161 600/150mg
n=12 Participants
|
VT-1161 1200/300mg
n=14 Participants
|
Matching Placebo
n=12 Participants
|
|---|---|---|---|---|
|
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
VT-1161 200/50mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VT-1161 600/150mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VT-1161 1200/300mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VT-1161 200/50mg
n=12 participants at risk
|
VT-1161 600/150mg
n=12 participants at risk
|
VT-1161 1200/300mg
n=14 participants at risk
|
Matching Placebo
n=12 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/14
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/12
|
|
Infections and infestations
Herpes Zoster
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/14
|
0.00%
0/12
|
|
Infections and infestations
Influenza
|
8.3%
1/12
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/12
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/14
|
8.3%
1/12
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/14
|
8.3%
1/12
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/12
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/12
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/12
|
0.00%
0/12
|
7.1%
1/14
|
8.3%
1/12
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/14
|
8.3%
1/12
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/14
|
8.3%
1/12
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/12
|
8.3%
1/12
|
0.00%
0/14
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/12
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinusitis
|
0.00%
0/12
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
|
0.00%
0/12
|
7.1%
1/14
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither institution nor principal investigator shall publish the results of the trial without prior written consent of the sponsor, which it may withhold in its sole discretion.
- Publication restrictions are in place
Restriction type: OTHER