Trial Outcomes & Findings for Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines (NCT NCT02939326)
NCT ID: NCT02939326
Last Updated: 2019-02-15
Results Overview
Subjects Achieving a 2 Grade Response At Maximum Frown On Any Study Day By Dose using the Facial Wrinkle Scale (FWS) The FWS is a four-point scale that indicates severity of GL as follows: 0 = none, 1 = mild, 2 = moderate, or 3 = severe. Each scale is a four-point photonumeric scale based on photographs incorporating each aspect to be evaluated in a stepwise manner.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
After single injection treatment up to 42 days
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Placebo
Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.
Placebo injection
|
EB-001 Dose 1 (1X)
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
EB-001 injection
|
EB-001 Dose 2 (3X)
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
EB-001 injection 3X Dose 1
|
EB-001 Dose 3 (9X)
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
EB-001 injection 9X dose 1
|
EB-001 Dose 4 (12X)
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
EB-001 injection 12X Dose 1
|
EB-001 Dose 5 (16X)
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
EB-001 injection 16X Dose 1
|
EB-001 Dose 6 (21X)
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
EB-001 injection 21X Dose 1
|
EB-001 Dose 7 (28X)
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
EB-001 injection 28X Dose 1
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Safety and Efficacy of a Single Treatment Cycle of EB-001 in Subjects With Glabellar Frown Lines
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.
Placebo injection
|
EB-001 Dose 1
n=5 Participants
1st Dose in escalation paradigm.
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 2
n=5 Participants
2nd Dose in escalation paradigm.
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 3
n=5 Participants
3rd Dose in escalation paradigm.
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 4
n=5 Participants
4th Dose in escalation paradigm.
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 5
n=5 Participants
5thDose in escalation paradigm.
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 6
n=5 Participants
6th Dose in escalation paradigm.
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 7
n=5 Participants
7th Dose in escalation paradigm.
Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 8.48 • n=39 Participants
|
52.0 years
STANDARD_DEVIATION 5.43 • n=41 Participants
|
39.4 years
STANDARD_DEVIATION 16.13 • n=35 Participants
|
52.2 years
STANDARD_DEVIATION 9.36 • n=31 Participants
|
50.8 years
STANDARD_DEVIATION 6.50 • n=146 Participants
|
45.4 years
STANDARD_DEVIATION 11.39 • n=19 Participants
|
53.2 years
STANDARD_DEVIATION 4.66 • n=147 Participants
|
42.6 years
STANDARD_DEVIATION 10.26 • n=193 Participants
|
47.9 years
STANDARD_DEVIATION 10.29
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
5 Participants
n=147 Participants
|
5 Participants
n=193 Participants
|
38 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
3 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=147 Participants
|
5 Participants
n=193 Participants
|
30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=39 Participants
|
5 participants
n=41 Participants
|
5 participants
n=35 Participants
|
5 participants
n=31 Participants
|
5 participants
n=146 Participants
|
5 participants
n=19 Participants
|
5 participants
n=147 Participants
|
5 participants
n=193 Participants
|
42 participants
|
PRIMARY outcome
Timeframe: After single injection treatment up to 42 daysPopulation: mITT
Subjects Achieving a 2 Grade Response At Maximum Frown On Any Study Day By Dose using the Facial Wrinkle Scale (FWS) The FWS is a four-point scale that indicates severity of GL as follows: 0 = none, 1 = mild, 2 = moderate, or 3 = severe. Each scale is a four-point photonumeric scale based on photographs incorporating each aspect to be evaluated in a stepwise manner.
Outcome measures
| Measure |
Placebo
n=7 Participants
Single Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.
Placebo injection
|
EB-001 Dose 1 (1X)
n=5 Participants
1st Dose in escalation paradigm.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 2 (3X)
n=5 Participants
2nd dose in escalation paradigm, 3X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 3 (9X)
n=5 Participants
3rd Dose in escalation paradigm, 9X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 4 (12X)
n=5 Participants
4th Dose in escalation paradigm, 12X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 5 (16X)
n=5 Participants
5th Dose in escalation paradigm, 16X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 6 (21X)
n=5 Participants
6th Dose in escalation paradigm, 21X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 7 (28X)
n=5 Participants
7th Dose in escalation paradigm, 28X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
|---|---|---|---|---|---|---|---|---|
|
Investigator's Assessment of GL Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS).
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EB-001 Dose 1 (1X)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EB-001 Dose 2 (3X)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EB-001 Dose 3 (9X)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EB-001 Dose 4 (12X)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EB-001 Dose 5 (16X)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EB-001 Dose 6 (21X)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EB-001 Dose 7 (28X)
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=7 participants at risk
Injection of placebo into five (5) 0.1 mL IM injections into glabellar area.
Placebo injection
|
EB-001 Dose 1 (1X)
n=5 participants at risk
1st Dose in escalation paradigm.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 2 (3X)
n=5 participants at risk
2nd dose in escalation paradigm, 3X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 3 (9X)
n=5 participants at risk
3rd Dose in escalation paradigm, 9X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 4 (12X)
n=5 participants at risk
4th Dose in escalation paradigm, 12X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 5 (16X)
n=5 participants at risk
5th Dose in escalation paradigm, 16X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area
|
EB-001 Dose 6 (21X)
n=5 participants at risk
6th Dose in escalation paradigm, 21X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
EB-001 Dose 7 (28X)
n=5 participants at risk
7th Dose in escalation paradigm, 28X Dose 1.
Single Injection of active drug into five (5) 0.1 mL IM injections into glabellar area.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/7 • 42 Days
|
20.0%
1/5 • Number of events 1 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 42 Days
|
0.00%
0/5 • 42 Days
|
20.0%
1/5 • Number of events 1 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
20.0%
1/5 • Number of events 1 • 42 Days
|
20.0%
1/5 • Number of events 1 • 42 Days
|
|
Infections and infestations
Flu-like Symptoms
|
0.00%
0/7 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
20.0%
1/5 • Number of events 1 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
0.00%
0/5 • 42 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place