Glabellar Rhytides
Conditions
Brief summary
A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.
Interventions
BIOLOGICALbotulinum toxin Type A
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* moderate or severe frown lines * facial laser treatment between 4 to 8 weeks prior to Day 1
Exclusion criteria
* previous use of botulinum toxin for any indication * diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis * microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months * facial cosmetic procedures within the last 6 Months * treatment to forehead, brow, nose or midface areas with any filler within the last 12 months * use of a new topical skin care product within 1 month of the screening * any prior forehead or periorbital surgery or brow lift * deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity * any facial skin infection or unhealed skin lesion * pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 1, Day 30 | The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 1, Day 14, Day 90, Day 120 | The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported. |
| Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 1, Day 14, Day 30, Day 90, Day 120 | The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported. |
| Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 1, Day 14, Day 30, Day 90, Day 120 | The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported. |
| Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 1, Day 14, Day 30, Day 90, Day 120 | The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1. | 185 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 12 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A |
|---|---|
| Age, Continuous | 44.8 Years STANDARD_DEVIATION 8.16 |
| Sex: Female, Male Female | 180 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 185 |
| serious Total, serious adverse events | 0 / 185 |
Outcome results
Primary
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Time frame: Day 1, Day 30
Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | 97.1 Percentage of Subjects |
Secondary
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Time frame: Day 1, Day 14, Day 90, Day 120
Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 14 | 97.1 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 90 | 90.2 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 120 | 81.5 Percentage of Subjects |
Secondary
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Time frame: Day 1, Day 14, Day 30, Day 90, Day 120
Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 14 | 62.7 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 30 | 65.7 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 90 | 65.7 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 120 | 62.7 Percentage of Subjects |
Secondary
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Time frame: Day 1, Day 14, Day 30, Day 90, Day 120
Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1 and had data at the noted time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 14 | 90.1 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 30 | 93.1 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 90 | 81.5 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction | Day 120 | 72.3 Percentage of Subjects |
Secondary
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest
The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
Time frame: Day 1, Day 14, Day 30, Day 90, Day 120
Population: Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 14 | 59.9 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 30 | 58.4 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 90 | 50.9 Percentage of Subjects |
| Botulinum Toxin Type A | Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest | Day 120 | 49.1 Percentage of Subjects |