Trial Outcomes & Findings for Study of EB-001 in Facial Scar Reduction (NCT NCT03346902)
NCT ID: NCT03346902
Last Updated: 2019-01-08
Results Overview
Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 30
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Placebo
0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
|
EB001
EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of EB-001 in Facial Scar Reduction
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
|
EB001
n=8 Participants
EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
59 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Weight
|
87.28 kg
STANDARD_DEVIATION 25.528 • n=5 Participants
|
79.94 kg
STANDARD_DEVIATION 19.352 • n=7 Participants
|
82.38 kg
STANDARD_DEVIATION 21.055 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: mITT
Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.
Outcome measures
| Measure |
Placebo
n=4 Participants
0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
|
EB001
n=8 Participants
EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
|
|---|---|---|
|
Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))
|
0 Percentage reporting improvement
|
50 Percentage reporting improvement
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EB001
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)
|
EB001
n=8 participants at risk
EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)
|
|---|---|---|
|
Nervous system disorders
Asymmetry in facial features as a result of the temporal nerve being affected during the Mohs Surger
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • Number of events 1 • 90 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place