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, dose escalating study
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 IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | Week 2, 4, 8,12,18 | 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 | Week 2, 4, 8,12,18 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Vehicle
Vehicle: Vehicle Formulation | 13 |
| Dose 1 botulinum toxin, Type A, topical liniment Dose 1x on Day 0 | 9 |
| Dose 2 botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0 | 9 |
| Dose 3 botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0 | 9 |
| Dose 4 botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0 | 8 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Dose 1 | Total | Dose 4 | Vehicle | Dose 3 | Dose 2 |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 48 Participants | 8 Participants | 13 Participants | 9 Participants | 9 Participants |
| IGA-C | 3.6 units on a scale STANDARD_DEVIATION 0.5 | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.5 units on a scale STANDARD_DEVIATION 0.4 | 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 46 Participants | 8 Participants | 13 Participants | 8 Participants | 9 Participants |
| Region of Enrollment United States | 9 participants | 48 participants | 8 participants | 13 participants | 9 participants | 9 participants |
| Sex: Female, Male Female | 8 Participants | 43 Participants | 8 Participants | 11 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 0 Participants | 2 Participants | 2 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 | 3.4 units on a scale STANDARD_DEVIATION 0.5 | 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 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 13 | 0 / 9 | 1 / 9 | 0 / 9 | 1 / 8 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 |
Outcome results
Primary
Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle | 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 |
| Dose 1 | Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 | 3 Participants |
| Dose 2 | Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 | 4 Participants |
| Dose 3 | 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 |
| Dose 4 | Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 | 1 Participants |
Secondary
Total Number of Observations With a Response Defined as IGA-C Score ≤ 2
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, 8,12,18
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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vehicle | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | 16 Observations |
| Dose 1 | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | 17 Observations |
| Dose 2 | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | 22 Observations |
| Dose 3 | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | 16 Observations |
| Dose 4 | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | 9 Observations |
Secondary
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vehicle | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | 20 Observations |
| Dose 1 | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | 19 Observations |
| Dose 2 | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | 26 Observations |
| Dose 3 | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | 15 Observations |
| Dose 4 | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | 8 Observations |