Trial Outcomes & Findings for ET-01 in Subjects With Lateral Canthal Lines, LCL-208 (NCT NCT03839693)
NCT ID: NCT03839693
Last Updated: 2022-08-23
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
75 participants
Primary outcome timeframe
Week 4
Results posted on
2022-08-23
Participant Flow
Participants were recruited from five medical centers between October 2018 and March 2019.
A total of N=88 subjects were screened; N=75 were found eligible and were randomized and treated.
Participant milestones
| Measure |
Vehicle
Vehicle
Vehicle: Vehicle Formulation
|
ET-01 345U
botulinum toxin, Type A, Dose 1, 345U
lower dose of botulinum toxin, Type A: topical liniment
|
ET-01 1100U
botulinum toxin, Type A, Dose 2, 1100U
higher dose of botulinum toxin, Type A: topical liniment
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
20
|
|
Overall Study
COMPLETED
|
23
|
28
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
Reasons for withdrawal
| Measure |
Vehicle
Vehicle
Vehicle: Vehicle Formulation
|
ET-01 345U
botulinum toxin, Type A, Dose 1, 345U
lower dose of botulinum toxin, Type A: topical liniment
|
ET-01 1100U
botulinum toxin, Type A, Dose 2, 1100U
higher dose of botulinum toxin, Type A: topical liniment
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
subject moved out of the area
|
1
|
0
|
0
|
Baseline Characteristics
ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Baseline characteristics by cohort
| Measure |
Vehicle
n=25 Participants
Vehicle
Vehicle: Vehicle Formulation
|
ET-01 345U
n=30 Participants
botulinum toxin, Type A, Lower Dose 1, 345U
botulinum toxin, Type A: topical liniment
|
ET-01 1100U
n=20 Participants
botulinum toxin, Type A, Higher Dose 2, 1100U
botulinum toxin, Type A: topical liniment
|
Total
n=75 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
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
IGA-C
|
3.3 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.4 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
|
3.7 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.4 • 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=23 Participants
Vehicle
Vehicle: Vehicle Formulation
|
ET-01 345U
n=30 Participants
botulinum toxin, Type A, Dose 1
botulinum toxin, Type A: topical liniment
|
ET-01 1100U
n=19 Participants
botulinum toxin, Type A, Dose 2
botulinum toxin, Type A: topical liniment
|
|---|---|---|---|
|
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
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8,12,18, and 26Population: 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 change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject 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 a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
Outcome measures
| Measure |
Vehicle
n=162 Observations
Vehicle
Vehicle: Vehicle Formulation
|
ET-01 345U
n=202 Observations
botulinum toxin, Type A, Dose 1
botulinum toxin, Type A: topical liniment
|
ET-01 1100U
n=131 Observations
botulinum toxin, Type A, Dose 2
botulinum toxin, Type A: topical liniment
|
|---|---|---|---|
|
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
|
1 Observations
|
5 Observations
|
5 Observations
|
SECONDARY outcome
Timeframe: Week 4, 8,and 12Population: 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 change by at least two ordinals in 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 an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12.
Outcome measures
| Measure |
Vehicle
n=68 Observations
Vehicle
Vehicle: Vehicle Formulation
|
ET-01 345U
n=88 Observations
botulinum toxin, Type A, Dose 1
botulinum toxin, Type A: topical liniment
|
ET-01 1100U
n=57 Observations
botulinum toxin, Type A, Dose 2
botulinum toxin, Type A: topical liniment
|
|---|---|---|---|
|
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12
|
4 Observations
|
6 Observations
|
8 Observations
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
ET-01 345U
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ET-01 1100U
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 |
Vehicle
n=25 participants at risk
Vehicle
Vehicle: Vehicle Formulation
|
ET-01 345U
n=30 participants at risk
botulinum toxin, Type A, Lower Dose 1, 345U
botulinum toxin, Type A: topical liniment
|
ET-01 1100U
n=20 participants at risk
botulinum toxin, Type A, Higher Dose 2, 1100U
botulinum toxin, Type A: topical liniment
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
|
Eye disorders
Blepharitis
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Gastrointestinal disorders
Cough
|
0.00%
0/25 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/25 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/25 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
|
Ear and labyrinth disorders
Ear infection
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Surgical and medical procedures
Endodontic procedure
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Reproductive system and breast disorders
Endometrial ablation
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
General disorders
Headache
|
8.0%
2/25 • Number of events 2 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Eye disorders
Hordeolum
|
16.0%
4/25 • Number of events 4 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Infections and infestations
Influenza
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Surgical and medical procedures
Mammoplasty
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
8.0%
2/25 • Number of events 2 • 26 weeks
|
3.3%
1/30 • Number of events 1 • 26 weeks
|
20.0%
4/20 • Number of events 4 • 26 weeks
|
|
Nervous system disorders
Nausea
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
3.3%
1/30 • Number of events 1 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rhinitis allergic
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
8.0%
2/25 • Number of events 2 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
4.0%
1/25 • Number of events 1 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
0.00%
0/20 • 26 weeks
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/25 • 26 weeks
|
0.00%
0/30 • 26 weeks
|
5.0%
1/20 • Number of events 1 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
8.0%
2/25 • Number of events 2 • 26 weeks
|
6.7%
2/30 • Number of events 2 • 26 weeks
|
5.0%
1/20 • Number of events 1 • 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