Crow's Feet, Lateral Canthal Lines
Conditions
Brief summary
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Detailed description
This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.
Interventions
BIOLOGICALVehicle
Vehicle Formulation
BIOLOGICALbotulinum toxin, Type A
botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
Sponsors
Eirion Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
different doses are packaged in identical containers
Intervention model description
parallel dose groups
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 25 - 65 years of age * minimal to moderate Crow's Feet wrinkles at rest * moderate to severe Crow's Feet wrinkles on contraction * willingness to refrain from any product affecting skin remodeling * female subjects must be not pregnant and non-lactating
Exclusion criteria
* history of adverse reactions to any prior botulinum toxin treatments * history of vaccination or non-response to any prior botulinum toxin treatments * botulinum toxin treatment in the prior 6 months * present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or dry eye * history of peri-ocular surgery, brow lift or related procedures * procedures affecting the lateral canthal region in the prior 12 months * application of topical prescription medication to the treatment area * female subjects who are pregnant or are nursing a child
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | Week 2, 4, 8,12, and 18 | 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. |
| Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | Week 2, 4, 8,12, and 18 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from six medical centers between August and October 2018.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Vehicle / Placebo formulation
Vehicle: Vehicle Formulation, administered once, topically, at Baseline | 26 |
| Dose 1 lower dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline | 26 |
| Dose 2 higher dose of ET-01
botulinum toxin, Type A: botulinum toxin, Type A, Dose 2, administered once, topically, at Baseline | 27 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Total | Dose 2 | Vehicle | Dose 1 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 26 Participants | 25 Participants | 26 Participants |
| Age, Continuous | 50.6 years STANDARD_DEVIATION 8.1 | 51.4 years STANDARD_DEVIATION 7.3 | 49.3 years STANDARD_DEVIATION 9 | 51.3 years STANDARD_DEVIATION 8.2 |
| IGA-C | 3.6 units on a scale STANDARD_DEVIATION 0.5 | 3.6 units on a scale STANDARD_DEVIATION 0.5 | 3.7 units on a scale STANDARD_DEVIATION 0.4 | 3.6 units on a scale STANDARD_DEVIATION 0.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 23 Participants | 22 Participants | 24 Participants |
| Region of Enrollment United States | 79 participants | 27 participants | 26 participants | 26 participants |
| Sex: Female, Male Female | 65 Participants | 21 Participants | 20 Participants | 24 Participants |
| Sex: Female, Male Male | 14 Participants | 6 Participants | 6 Participants | 2 Participants |
| SSA-C | 3.6 units on a scale STANDARD_DEVIATION 0.5 | 3.6 units on a scale STANDARD_DEVIATION 0.5 | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.8 units on a scale STANDARD_DEVIATION 0.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 1 / 27 |
| other Total, other adverse events | 4 / 26 | 3 / 26 | 2 / 27 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 3 / 27 |
Outcome results
Primary
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
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.
Time frame: Week 4
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle | 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 |
| Dose 1 | 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 | 1 Participants |
| Dose 2 | 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 |
Secondary
Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
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.
Time frame: Week 2, 4, 8,12, and 18
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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vehicle | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | 33 Observations |
| Dose 1 | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | 18 Observations |
| Dose 2 | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | 44 Observations |
Secondary
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
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.
Time frame: Week 2, 4, 8,12, and 18
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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vehicle | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | 30 Observations |
| Dose 1 | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | 8 Observations |
| Dose 2 | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | 17 Observations |