Crow's Feet, Lateral Canthal Lines, LCL
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 (LCL), 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
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
vehicle controlled, parallel group
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 Post Baseline Visit | Week 1, 2, 4, 8,12,18, and 26 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from three medical centers between February 2019 and October 2019
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Vehicle, topical liniment, administered once at baseline
Vehicle: Vehicle Formulation | 19 |
| ET-01 1610U botulinum toxin, Type A, topical liniment, administered once at baseline
botulinum toxin, Type A: topical liniment | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Vehicle | ET-01 1610U | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| IGA-C | 3.4 units on a scale STANDARD_DEVIATION 0.5 | 3.4 units on a scale STANDARD_DEVIATION 0.5 | 3.4 units on a scale STANDARD_DEVIATION 0.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants | 38 Participants |
| Region of Enrollment United States | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| SSA-C | 3.6 units on a scale STANDARD_DEVIATION 0.5 | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.6 units on a scale STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 6 / 19 | 2 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
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 reached Week 4. 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 | 3 Participants |
| ET-01 1610U | 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: 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.
| 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 | 8 Observations |
| ET-01 1610U | Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit | 12 Observations |
Secondary
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit
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.
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 in SSA-C Score ≥ 2 at Any Post Baseline Visit | 15 Observations |
| ET-01 1610U | Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit | 20 Observations |