Crow's Feet Lines, Frown Lines, Glabellar Lines, Upper Facial Rhytides
Conditions
Brief summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).
Interventions
BIOLOGICALbotulinum toxin Type A (44U)
44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
BIOLOGICALbotulinum toxin Type A (32U)
32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
-Moderate to severe Crow's Feet Lines and Frown Lines
Exclusion criteria
* Current or previous botulinum toxin treatment of any serotype * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months * Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year * Medium-depth or deep facial peels within 5 years * Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | Day 30 | The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | Baseline, Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : When I look in the mirror, my facial lines make me look older than I want to look score. |
| Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | Baseline, Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: My facial lines make me look less attractive than I want to look score. |
| Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL) | Day 30 | Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported. |
| Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | Baseline, Day 30 | Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30. |
| Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire | Day 30 | Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported. |
| Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | Baseline, Day 30 | The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: My facial lines make me look tired score. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A (44U) 44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. | 48 |
| Botulinum Toxin Type A (32U) 32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles. | 53 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Other Miscellaneous Reasons | 1 | 0 |
| Overall Study | Personal Reasons | 4 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A (44U) | Botulinum Toxin Type A (32U) | Total |
|---|---|---|---|
| Age, Customized ≤ 50 years | 29 participants | 40 participants | 69 participants |
| Age, Customized > 50 years | 19 participants | 13 participants | 32 participants |
| Sex: Female, Male Female | 45 Participants | 48 Participants | 93 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 47 | 22 / 53 |
| serious Total, serious adverse events | 1 / 47 | 4 / 53 |
Outcome results
Primary
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
Time frame: Day 30
Population: Intent-to-treat population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (44U) | Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | 89.6 percentage of participants |
| Botulinum Toxin Type A (32U) | Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A) | 84.9 percentage of participants |
Secondary
Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire
Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.
Time frame: Day 30
Population: Intent-to-treat population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (44U) | Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire | 81.3 percentage of participants |
| Botulinum Toxin Type A (32U) | Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire | 81.1 percentage of participants |
Secondary
Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL)
Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.
Time frame: Day 30
Population: Intent-to-treat population included all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (44U) | Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL) | 87.6 percentage of participants |
| Botulinum Toxin Type A (32U) | Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL) | 77.4 percentage of participants |
Secondary
Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline
Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30.
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (44U) | Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | 54.3 percentage of participants |
| Botulinum Toxin Type A (32U) | Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline | 56.9 percentage of participants |
Secondary
Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : When I look in the mirror, my facial lines make me look older than I want to look score.
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 2 scores ≥2 at Baseline are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (44U) | Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | 84.8 percentage of participants |
| Botulinum Toxin Type A (32U) | Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30 | 88.0 percentage of participants |
Secondary
Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: My facial lines make me look less attractive than I want to look score.
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 5 scores ≥2 at Baseline are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (44U) | Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | 73.9 percentage of participants |
| Botulinum Toxin Type A (32U) | Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30 | 72.5 percentage of participants |
Secondary
Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30
The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: My facial lines make me look tired score.
Time frame: Baseline, Day 30
Population: Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 8 scores ≥ 3 at Baseline were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (44U) | Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | 86.0 percentage of participants |
| Botulinum Toxin Type A (32U) | Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30 | 69.4 percentage of participants |