Glabellar Frown Lines
Conditions
Brief summary
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
Interventions
BIOLOGICALbotulinum toxin Type A
botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
DRUGnormal saline (placebo)
Normal saline (placebo) injected into the glabellar region on Day 0.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe glabellar wrinkles (frown lines)
Exclusion criteria
* Previous treatment with botulinum toxin therapy of any serotype * Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months * Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months * Mid-facial or periorbital treatment with non-permanent soft tissue fillers * Subjects planning a facial cosmetic procedure or visible scars * Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery) * Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * History of facial nerve palsy * A planned extended absence during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 | Day 30 | Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 | Day 30 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild. |
| Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60 | Day 60 | The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. | 20 |
| Placebo (Normal Saline) Normal Saline (placebo) injected into the glabellar region on Day 0. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A | Placebo (Normal Saline) | Total |
|---|---|---|---|
| Age Continuous | 46.3 Years STANDARD_DEVIATION 12.8 | 54.5 Years STANDARD_DEVIATION 7.1 | 50.4 Years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30
Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.
Time frame: Day 30
Population: Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Type A | Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 | 94.7 Percentage of participants | 0.84 |
| Placebo (Normal Saline) | Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 | 0.00 Percentage of participants | 0 |
Secondary
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30
The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.
Time frame: Day 30
Population: Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 | 100 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 | 10 Percentage of participants |
Secondary
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60
The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.
Time frame: Day 60
Population: Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60 | 77.8 Percentage of participants |
| Placebo (Normal Saline) | Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60 | 5.3 Percentage of participants |