Trial Outcomes & Findings for ET-01 in Subjects With Lateral Canthal Lines, LCL-207 (NCT NCT03655691)
NCT ID: NCT03655691
Last Updated: 2022-04-21
Results Overview
Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Week 4
Results posted on
2022-04-21
Participant Flow
Participants were recruited from six medical centers between August and October 2018.
A total of N=104 subjects were screened; N=80 were found eligible; N=1 subject withdrew consent prior to treatment assignment; N=79 were randomized.
Participant milestones
| Measure |
Vehicle
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation, administered once, topically, at Baseline
|
Dose 1
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
|
Dose 2
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
27
|
|
Overall Study
COMPLETED
|
24
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Vehicle
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation, administered once, topically, at Baseline
|
Dose 1
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
|
Dose 2
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
ET-01 in Subjects With Lateral Canthal Lines, LCL-207
Baseline characteristics by cohort
| Measure |
Vehicle
n=26 Participants
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation, administered once, topically, at Baseline
|
Dose 1
n=26 Participants
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
|
Dose 2
n=27 Participants
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, Dose 2, administered once, topically, at Baseline
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 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
|
2 Participants
n=5 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 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
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
27 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
IGA-C
|
3.7 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.5 • n=4 Participants
|
|
SSA-C
|
3.5 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Intent-To-Treat (ITT) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available.
Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
Outcome measures
| Measure |
Vehicle
n=24 Participants
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation, administered once, topically, at Baseline
|
Dose 1
n=26 Participants
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
|
Dose 2
n=26 Participants
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
|
|---|---|---|---|
|
Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
|
4 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8,12, and 18Population: Intent-To-Treat (ITT) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available.
Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.
Outcome measures
| Measure |
Vehicle
n=146 Observations
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation, administered once, topically, at Baseline
|
Dose 1
n=151 Observations
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
|
Dose 2
n=152 Observations
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
|
|---|---|---|---|
|
Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
|
33 Observations
|
18 Observations
|
44 Observations
|
SECONDARY outcome
Timeframe: Week 2, 4, 8,12, and 18Population: Intent-To-Treat (ITT) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available.
Total number of observations with a Score of ≤ 2 on the Subjects Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.
Outcome measures
| Measure |
Vehicle
n=146 Observations
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation, administered once, topically, at Baseline
|
Dose 1
n=151 Observations
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
|
Dose 2
n=152 Observations
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
|
|---|---|---|---|
|
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
|
30 Observations
|
8 Observations
|
17 Observations
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose 2
Serious events: 3 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vehicle
n=26 participants at risk
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation
|
Dose 1
n=26 participants at risk
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, Dose 1
|
Dose 2
n=27 participants at risk
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, Dose 2
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental death
|
0.00%
0/26 • 26 Weeks
|
0.00%
0/26 • 26 Weeks
|
3.7%
1/27 • Number of events 1 • 26 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • 26 Weeks
|
0.00%
0/26 • 26 Weeks
|
3.7%
1/27 • Number of events 1 • 26 Weeks
|
|
Nervous system disorders
Depression
|
0.00%
0/26 • 26 Weeks
|
0.00%
0/26 • 26 Weeks
|
3.7%
1/27 • Number of events 1 • 26 Weeks
|
Other adverse events
| Measure |
Vehicle
n=26 participants at risk
Vehicle / Placebo formulation
Vehicle: Vehicle Formulation
|
Dose 1
n=26 participants at risk
lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, Dose 1
|
Dose 2
n=27 participants at risk
higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, Dose 2
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Number of events 1 • 26 Weeks
|
3.8%
1/26 • Number of events 1 • 26 Weeks
|
3.7%
1/27 • Number of events 1 • 26 Weeks
|
|
Gastrointestinal disorders
Large intestine benign neoplasm
|
7.7%
2/26 • Number of events 2 • 26 Weeks
|
0.00%
0/26 • 26 Weeks
|
0.00%
0/27 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • 26 Weeks
|
3.8%
1/26 • Number of events 1 • 26 Weeks
|
3.7%
1/27 • Number of events 1 • 26 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.8%
1/26 • Number of events 1 • 26 Weeks
|
3.8%
1/26 • Number of events 1 • 26 Weeks
|
0.00%
0/27 • 26 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Study Results are considered Confidential Information that may not be published or disclosed without Sponsor's written consent for a period of five (5) years after completion of the Study.
- Publication restrictions are in place
Restriction type: OTHER