Glabellar Frown Lines
Conditions
Keywords
Glabellar Lines, Botulinum toxin, Type A
Brief summary
The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult subjects.
Detailed description
Up to five hundred and thirty (530) subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study. Subjects with moderate-to-severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450. Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.
Interventions
BIOLOGICALDWP-450 (Botulinum purified neurotoxin, Type A)
Botulinum toxin, Type A
Sponsors
PPD Development, LP
Evolus, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open label safety study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be an adult 18 years of age and over * Subject is able to provide informed consent and comply with study instructions * Subject has moderate-to-severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS * Subject is willing and able to complete the entire course of the study
Exclusion criteria
* Previous treatment with botulinum toxin of any serotype in any area within the last 6 months * Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months * Previous insertion of permanent material in the glabellar area * Planned treatment with botulinum toxin of any serotype in any other body region during the study period * Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow) * Energy based or cryo-therapy based treatment of facial muscles superior to the lateral canthus * Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine) * Inability to substantially lessen glabellar frown lines even by physically spreading them apart * Marked facial asymmetry * Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis * History of facial nerve palsy * Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin * Any active infection in the area of the injection sites * Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis) * Evidence of recent alcohol or drug abuse * Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study * Pregnant, nursing or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception * Known allergy or hypersensitivity to botulinum toxin preparation * Participation in another interventional clinical study within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year | 365 days | The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown | 365 days | Proportion of subjects with an improvement of 1 point or more (i.e., ≥1 point responders) on the GLS at rest at end of study/early termination: by Investigator assessment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin, Type A DWP-450 (Botulinum toxin, Type A)
DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A | 570 |
| Total | 570 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 37 |
| Overall Study | moved away | 10 |
| Overall Study | Pregnancy | 2 |
| Overall Study | scheduling conflicts | 15 |
| Overall Study | various | 16 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Botulinum Toxin, Type A |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 51 Participants |
| Age, Categorical Between 18 and 65 years | 519 Participants |
| Sex: Female, Male Female | 510 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 228 / 570 |
| serious Total, serious adverse events | 7 / 570 |
Outcome results
Primary
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
Time frame: 365 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Botulinum Toxin, Tyoe A | The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year | 235 Participants |
Other Pre-specified
Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown
Proportion of subjects with an improvement of 1 point or more (i.e., ≥1 point responders) on the GLS at rest at end of study/early termination: by Investigator assessment
Time frame: 365 days
Population: By Investigator assessment, 500 subjects had a GLS score at rest \>0 (i.e., 1, 2 or 3) at baseline and therefore could potentially have had a ≥1 point improvement in GLS score at rest at a post-baseline visit; 64 subjects were missing the EOS GLS assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Botulinum Toxin, Tyoe A | Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown | 355 Participants |