Trial Outcomes & Findings for ET-01 in Subjects With Lateral Canthal Lines (NCT NCT03326856)

Last Updated: 2022-04-21

Results Overview

Composite of Investigators Global Assessment \& Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

Week 4

Results posted on

2022-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Vehicle Vehicle Vehicle: Vehicle Formulation	Dose 1 botulinum toxin, Type A, topical liniment Dose 1x on Day 0	Dose 2 botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	Dose 3 botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	Dose 4 botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Overall Study STARTED	13	9	9	9	8
Overall Study COMPLETED	12	8	9	9	8
Overall Study NOT COMPLETED	1	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Vehicle Vehicle: Vehicle Formulation	Dose 1 botulinum toxin, Type A, topical liniment Dose 1x on Day 0	Dose 2 botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	Dose 3 botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	Dose 4 botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Overall Study Lost to Follow-up	1	1	0	0	0

Baseline Characteristics

ET-01 in Subjects With Lateral Canthal Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle n=13 Participants Vehicle Vehicle: Vehicle Formulation	Dose 1 n=9 Participants botulinum toxin, Type A, topical liniment Dose 1x on Day 0	Dose 2 n=9 Participants botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	Dose 3 n=9 Participants botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	Dose 4 n=8 Participants botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0	Total n=48 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	48 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	43 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	46 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Region of Enrollment United States	13 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	9 participants n=4 Participants	8 participants n=21 Participants	48 participants n=8 Participants
IGA-C	3.5 units on a scale STANDARD_DEVIATION 0.4 • n=5 Participants	3.6 units on a scale STANDARD_DEVIATION 0.5 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=4 Participants	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=21 Participants	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=8 Participants
SSA-C	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	3.6 units on a scale STANDARD_DEVIATION 0.5 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=4 Participants	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=21 Participants	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=8 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Per Protocol (PP) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available.

Outcome measures

Outcome measures
Measure	Vehicle n=13 Participants Vehicle Vehicle: Vehicle Formulation	Dose 1 n=8 Participants botulinum toxin, Type A, topical liniment Dose 1x on Day 0	Dose 2 n=9 Participants botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	Dose 3 n=9 Participants botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	Dose 4 n=8 Participants botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2	2 Participants	3 Participants	4 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 2, 4, 8,12,18

Population: Per Protocol (PP) 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

Outcome measures
Measure	Vehicle n=64 Observations Vehicle Vehicle: Vehicle Formulation	Dose 1 n=40 Observations botulinum toxin, Type A, topical liniment Dose 1x on Day 0	Dose 2 n=45 Observations botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	Dose 3 n=45 Observations botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	Dose 4 n=40 Observations botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Total Number of Observations With a Response Defined as IGA-C Score ≤ 2	16 Observations	17 Observations	22 Observations	16 Observations	9 Observations

SECONDARY outcome

Timeframe: Week 2, 4, 8,12,18

Population: Per Protocol (PP) 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 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 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.