Trial Outcomes & Findings for ET-01 in Subjects With Lateral Canthal Lines, LCL-209 (NCT NCT03912805)

Last Updated: 2022-07-28

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

38 participants

Primary outcome timeframe

Week 4

Results posted on

2022-07-28

Participant Flow

Participants were recruited from three medical centers between February 2019 and October 2019

A total of N=45 subjects were screened; N=38 were found eligible; N=7 subjects screen failed prior to treatment assignment; N=38 were randomized

Participant milestones

Participant milestones
Measure	Vehicle Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation	ET-01 1610U botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment, 1610U
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ET-01 in Subjects With Lateral Canthal Lines, LCL-209

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 4

Population: Intent-To-Treat (ITT) population defined as all treated subjects who reached Week 4. No imputation was performed when only incomplete data were available.

Outcome measures

Outcome measures
Measure	Vehicle n=19 Participants Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation	ET-01 1610U n=19 Participants botulinum toxin, Type A, topical liniment, administered once at baseline 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	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8,12,18, and 26

Population: 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.

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

Outcome measures
Measure	Vehicle n=132 Observations Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation	ET-01 1610U n=132 Observations botulinum toxin, Type A, topical liniment, administered once at baseline 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	8 Observations	12 Observations

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8,12,18, and 26

Population: 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 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

Outcome measures
Measure	Vehicle n=132 Observations Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation	ET-01 1610U n=132 Observations botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit	15 Observations	20 Observations

Adverse Events

Vehicle

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

ET-01 1610U

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vehicle n=19 participants at risk Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation	ET-01 1610U n=19 participants at risk botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	0.00% 0/19 • 26 Weeks	5.3% 1/19 • Number of events 1 • 26 Weeks
Skin and subcutaneous tissue disorders Thermal Burn	0.00% 0/19 • 26 Weeks	5.3% 1/19 • Number of events 1 • 26 Weeks
Skin and subcutaneous tissue disorders Folliculitis	0.00% 0/19 • 26 Weeks	5.3% 1/19 • Number of events 1 • 26 Weeks
Surgical and medical procedures Endodontic Procedure	5.3% 1/19 • Number of events 1 • 26 Weeks	0.00% 0/19 • 26 Weeks
General disorders Oral Herpes	5.3% 1/19 • Number of events 1 • 26 Weeks	0.00% 0/19 • 26 Weeks
Renal and urinary disorders Nephrolithiasis	5.3% 1/19 • Number of events 1 • 26 Weeks	0.00% 0/19 • 26 Weeks
Renal and urinary disorders Urinary Tract Infection	10.5% 2/19 • Number of events 2 • 26 Weeks	0.00% 0/19 • 26 Weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 1/19 • Number of events 1 • 26 Weeks	0.00% 0/19 • 26 Weeks
Eye disorders Hordeolum	5.3% 1/19 • Number of events 1 • 26 Weeks	0.00% 0/19 • 26 Weeks
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	5.3% 1/19 • Number of events 1 • 26 Weeks	0.00% 0/19 • 26 Weeks

Additional Information

Patrick Murphy

Clinical Research Management Group

Phone: (866) 337-1868

Email: [email protected]

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

Measure	Vehicle n=19 Participants Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation	ET-01 1610U n=19 Participants botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment	Total n=38 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
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	19 Participants n=5 Participants	19 Participants n=7 Participants	38 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	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
IGA-C	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants
SSA-C	3.6 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=7 Participants	3.6 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants