Trial Outcomes & Findings for A Trial to Evaluate the Safety and and Tolerability of DBI-001 in Patients With Tinea Pedis (NCT NCT04152226)
NCT ID: NCT04152226
Last Updated: 2025-06-17
Results Overview
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
COMPLETED
PHASE2
12 participants
28 days
2025-06-17
Participant Flow
Participant milestones
| Measure |
Cohort 1
Cohort 1 Dose 10\^6CFUs/ml
Janthinobacterium lividum: Investigational Product
|
Cohort 2
Cohort 2 Dose 10\^7CFUs/ml
Janthinobacterium lividum: Investigational Product
|
Cohort 3
Cohort 3 - Dose 10\^8CFUs/ml
Janthinobacterium lividum: Investigational Product
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Evaluate the Safety and and Tolerability of DBI-001 in Patients With Tinea Pedis
Baseline characteristics by cohort
| Measure |
Cohort 1
n=4 Participants
Cohort 1 Dose 10\^6CFUs/ml of J. lividum
Janthinobacterium lividum: Investigational Product
|
Cohort 2
n=4 Participants
Cohort 2 Dose 10\^7CFUs/ml of J. lividum
Janthinobacterium lividum: Investigational Product
|
Cohort 3
n=4 Participants
Cohort 3 - Dose 10\^8CFUs/ml of J. Lividum
Janthinobacterium lividum: Investigational Product
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 13.74 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 15.95 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 12.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: By number of feet treated
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Outcome measures
| Measure |
0=None Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
1=Mild Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
2=Moderate Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
3=Severe Count n=24
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
|---|---|---|---|---|
|
Safety Evaluation Cohort 1
Pain Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pruritus 1 Hour Post application
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pruritus Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pruritus Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pruritus Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pruritus Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pruritus Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Erythema Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Erythema 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Erythema Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Erythema Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Erythema Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Erythema Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Erythema Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Edema Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Edema 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Edema Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Edema Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Edema Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Edema Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Scabbing Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Scabbing 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Scabbing Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Scabbing Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Scabbing Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Scabbing Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Scabbing Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pain Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pain 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pain Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pain Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pain Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pain Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Pruritus Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 1
Edema Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
PRIMARY outcome
Timeframe: 28 daysPopulation: By number of feet treated
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Outcome measures
| Measure |
0=None Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
1=Mild Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
2=Moderate Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
3=Severe Count n=24
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
|---|---|---|---|---|
|
Safety Evaluation Cohort 2
Erythema Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Edema Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Edema 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pain Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pruritus Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pruritus 1 Hour Post application
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pruritus Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pruritus Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pruritus Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pruritus Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pruritus Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Erythema Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Erythema Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Erythema Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Erythema Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Edema Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pain Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Edema Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Edema Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Edema Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Edema Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Scabbing Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Scabbing 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Scabbing Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Scabbing Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Scabbing Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Scabbing Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Scabbing Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pain Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pain 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pain Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pain Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Pain Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Erythema Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 2
Erythema 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
PRIMARY outcome
Timeframe: 28 daysPopulation: By number of feet treated
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Outcome measures
| Measure |
0=None Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
1=Mild Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
2=Moderate Count n=24 (Percentage)
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
3=Severe Count n=24
n=8 Feet
Symptom of Pruritus, Erythema, Edema, Scabbing/crusting, Burning/Stinging on areas unaffected by tinea pedis (by number of feet treated)
|
|---|---|---|---|---|
|
Safety Evaluation Cohort 3
Erythema Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pruritus Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pruritus 1 Hour Post application
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pruritus Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pruritus Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pruritus Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pruritus Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pruritus Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Erythema Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Erythema 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Erythema Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Erythema Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Erythema Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Edema Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Edema 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Edema Day 2
|
8 Feet
|
00 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Edema Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Edema Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Edema Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Edema Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Scabbing Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Scabbing 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Scabbing Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Scabbing Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Scabbing Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Scabbing Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Scabbing Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pain Baseline
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pain 1 Hour Post
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pain Day 2
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pain Day 3
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pain Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pain Day 14
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Pain Day 28
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
|
Safety Evaluation Cohort 3
Erythema Day 7
|
8 Feet
|
0 Feet
|
0 Feet
|
0 Feet
|
Adverse Events
Cohort 1
Cohort 2
Cohort 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER