Facial Rhytides
Conditions
Brief summary
This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.
Interventions
DRUGbotulinum toxin Type A
Previous treatment with botulinum toxin Type A for treatment of facial lines
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation * Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Total Dose Per Treatment Period | 24 Months | Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Injection Interval Duration of Each Treatment Period | 24 Months | Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle. |
| Percent of Subjects Reporting Satisfaction With Treatment Effects | 24 Months | Percent of subjects reporting satisfaction with treatment effects per chart notes. |
Countries
Argentina
Participant flow
Pre-assignment details
In this retrospective chart review study, subjects received botulinum toxin Type A (BOTOX®) in study-defined Treatment Periods 1 and 3, and botulinum toxin Type A (Xeomin®) in Treatment Period 2. Data were evaluated as available for each Treatment Period.
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A Previous treatment with botulinum toxin Type A for treatment of facial lines | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A |
|---|---|
| Age, Customized ≥30 and <40 years | 5 Participants |
| Age, Customized ≥40 and <50 years | 31 Participants |
| Age, Customized ≥50 and <60 years | 33 Participants |
| Age, Customized ≥60 years | 35 Participants |
| Age, Customized Missing | 6 Participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Average Total Dose Per Treatment Period
Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.
Time frame: 24 Months
Population: All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A | Average Total Dose Per Treatment Period | Treatment Period 1 (BOTOX®) N=34 | 49.2 Units | Standard Deviation 12.77 |
| Botulinum Toxin Type A | Average Total Dose Per Treatment Period | Treatment Period 2 (Xeomin®) N=34 | 48.1 Units | Standard Deviation 15.18 |
| Botulinum Toxin Type A | Average Total Dose Per Treatment Period | Treatment Period 3 (BOTOX®) N=16 | 45.8 Units | Standard Deviation 4.68 |
Secondary
Inter-Injection Interval Duration of Each Treatment Period
Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.
Time frame: 24 Months
Population: All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A | Inter-Injection Interval Duration of Each Treatment Period | Treatment Period 1 (BOTOX®) N=110 | 180.3 Days | Full Range 94.4 |
| Botulinum Toxin Type A | Inter-Injection Interval Duration of Each Treatment Period | Treatment Period 2 (Xeomin®) N=106 | 144.3 Days | Full Range 113.55 |
| Botulinum Toxin Type A | Inter-Injection Interval Duration of Each Treatment Period | Treatment Period 3 (BOTOX®) N=76 | 176.9 Days | Full Range 91.43 |
Secondary
Percent of Subjects Reporting Satisfaction With Treatment Effects
Percent of subjects reporting satisfaction with treatment effects per chart notes.
Time frame: 24 Months
Population: All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A | Percent of Subjects Reporting Satisfaction With Treatment Effects | Treatment Period 2 (Xeomin®) N=74 | 33.7 Percentage of Subjects | Standard Deviation 39.29 |
| Botulinum Toxin Type A | Percent of Subjects Reporting Satisfaction With Treatment Effects | Treatment Period 3 (BOTOX®) N=67 | 90.3 Percentage of Subjects | Standard Deviation 17.56 |
| Botulinum Toxin Type A | Percent of Subjects Reporting Satisfaction With Treatment Effects | Treatment Period 1 (BOTOX®) N=80 | 99.0 Percentage of Subjects | Standard Deviation 6.68 |