Facial Rhytides, Glabellar Frown Lines
Conditions
Brief summary
This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).
Interventions
BIOLOGICALbotulinum toxin Type A
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
DRUGNormal Saline
Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe forehead lines
Exclusion criteria
* Current or previous botulinum toxin treatment of any serotype within one year * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis * Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery) * Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months * Oral retinoid therapy within one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | Day 30 | The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. |
| Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | Day 30 | The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines | Day 30 | Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30. |
| Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest | Baseline, Day 30 | The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. |
| Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest | Baseline, Day 30 | Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A (40 Units) Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. | 57 |
| Botulinum Toxin Type A (30 Units) Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. | 60 |
| Placebo (Normal Saline) Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1. | 58 |
| Total | 175 |
Baseline characteristics
| Characteristic | Total | Botulinum Toxin Type A (40 Units) | Botulinum Toxin Type A (30 Units) | Placebo (Normal Saline) |
|---|---|---|---|---|
| Age, Customized 45 to 65 years | 92 Participants | 26 Participants | 31 Participants | 35 Participants |
| Age, Customized <45 years | 75 Participants | 28 Participants | 25 Participants | 22 Participants |
| Age, Customized >65 years | 8 Participants | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Female | 152 Participants | 50 Participants | 50 Participants | 52 Participants |
| Sex: Female, Male Male | 23 Participants | 7 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 57 | 8 / 60 | 8 / 58 |
| serious Total, serious adverse events | 0 / 57 | 0 / 60 | 1 / 58 |
Outcome results
Primary
Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.
Time frame: Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (40 Units) | Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | 89.5 Percentage of participants |
| Botulinum Toxin Type A (30 Units) | Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | 85.0 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | 3.4 Percentage of participants |
Primary
Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation
The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.
Time frame: Day 30
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (40 Units) | Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | 87.7 Percentage of participants |
| Botulinum Toxin Type A (30 Units) | Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | 80.0 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation | 6.9 Percentage of participants |
Secondary
Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines
Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.
Time frame: Day 30
Population: Includes participants from the Intent-to-treat Population (all randomized participants) with a rating of very unsatisfied, unsatisfied or neutral in the Subject's Assessment of Satisfaction of Appearance at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (40 Units) | Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines | 94.4 Percentage of participants |
| Botulinum Toxin Type A (30 Units) | Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines | 81.0 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines | 1.8 Percentage of participants |
Secondary
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest
The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.
Time frame: Baseline, Day 30
Population: Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (40 Units) | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest | 91.1 Percentage of participants |
| Botulinum Toxin Type A (30 Units) | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest | 83.3 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest | 15.5 Percentage of participants |
Secondary
Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest
Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.
Time frame: Baseline, Day 30
Population: Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A (40 Units) | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest | 89.5 Percentage of participants |
| Botulinum Toxin Type A (30 Units) | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest | 88.3 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest | 17.2 Percentage of participants |