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
BIOLOGICALbotulinum toxin, Type A
topical liniment
BIOLOGICALVehicle
Vehicle Formulation
Sponsors
Eirion Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
sequential cohort, dose escalating study
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* females 25 - 65 years of age * minimal to moderate Crow's Feet wrinkles at rest * moderate to severe Crow's Feet on contraction * adequate vision to assess facial wrinkles in a mirror * willingness to refrain from products affecting skin remodeling * female subjects must be not pregnant and non-lactating * subjects should be in good general health
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 Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit | Week 1, 2, 4, 8,12,18, and 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. |
| Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 | Week 4, 8,and 12 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from five medical centers between October 2018 and March 2019.
Pre-assignment details
A total of N=88 subjects were screened; N=75 were found eligible and were randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Vehicle
Vehicle: Vehicle Formulation | 25 |
| ET-01 345U botulinum toxin, Type A, Lower Dose 1, 345U
botulinum toxin, Type A: topical liniment | 30 |
| ET-01 1100U botulinum toxin, Type A, Higher Dose 2, 1100U
botulinum toxin, Type A: topical liniment | 20 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 2 |
| Overall Study | subject moved out of the area | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Vehicle | ET-01 345U | ET-01 1100U | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 29 Participants | 19 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 25 Participants | 14 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| IGA-C | 3.3 units on a scale STANDARD_DEVIATION 0.4 | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.4 units on a scale STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 25 Participants | 30 Participants | 20 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| SSA-C | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.7 units on a scale STANDARD_DEVIATION 0.5 | 3.8 units on a scale STANDARD_DEVIATION 0.4 | 3.6 units on a scale STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 30 | 0 / 20 |
| other Total, other adverse events | 13 / 25 | 4 / 30 | 5 / 20 |
| serious Total, serious adverse events | 0 / 25 | 0 / 30 | 0 / 20 |
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 | 2 Participants |
| ET-01 345U | 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 | 0 Participants |
| ET-01 1100U | 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 |
Secondary
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vehicle | 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 |
| ET-01 345U | Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit | 5 Observations |
| ET-01 1100U | Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit | 5 Observations |
Secondary
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12
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.
Time frame: Week 4, 8,and 12
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 Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 | 4 Observations |
| ET-01 345U | Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 | 6 Observations |
| ET-01 1100U | Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 | 8 Observations |