Glabellar Frown Lines
Conditions
Keywords
Glabellar Lines, Botulinum purifies neurotoxin, Type A (DWP-450)
Brief summary
The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.
Detailed description
Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study. Subjects with moderate or 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. After each injection, subjects will be followed and are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible for repeat treatment. Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.
Interventions
BIOLOGICALBotulinum purified neurotoxin, Type A
The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml.
Sponsors
Evolus, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study): * Subjects must be an adult 18 years of age or 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 using the GLS * Subject is willing and able to complete the entire course of the study
Exclusion criteria
(A subject must not meet the following
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 |
|---|---|---|
| Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS) | 365 Days | GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. A 1-point decrease in GLS score is equivalent to a 1-point improvement on the GLS; as such, both meet the definition of a 1-point responder on the GLS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Neurotoxin, Type A DWP-450 (Botulinum purified neurotoxin, Type A) Injection
Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml. | 352 |
| Total | 352 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 32 |
| Overall Study | moving away/travelling/unable to complet | 6 |
| Overall Study | Pregnancy | 2 |
| Overall Study | various other reasons | 9 |
| Overall Study | work scheduling issues | 4 |
Baseline characteristics
| Characteristic | Botulinum Neurotoxin, Type A |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 33 Participants |
| Age, Categorical Between 18 and 65 years | 319 Participants |
| Sex: Female, Male Female | 331 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 352 |
| other Total, other adverse events | 141 / 352 |
| serious Total, serious adverse events | 7 / 352 |
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 Neurotoxin, Type A | The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year | 148 Participants |
Other Pre-specified
Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS)
GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. A 1-point decrease in GLS score is equivalent to a 1-point improvement on the GLS; as such, both meet the definition of a 1-point responder on the GLS
Time frame: 365 Days
Population: 323 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; 32 were missing the EOS GLS assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Neurotoxin, Type A | Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS) | 75.9 percentage of responders |