Trial Outcomes & Findings for Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (NCT NCT03014622)
NCT ID: NCT03014622
Last Updated: 2022-07-21
Results Overview
Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
303 participants
Primary outcome timeframe
Week 4
Results posted on
2022-07-21
Participant Flow
Outpatient, male or non-pregnant, non-nursing females, 18-75 years of age, and in good general health with moderate (2) or severe (3) glabellar lines during maximum frown based on the IGA-FWS and PFWS.
Participant milestones
| Measure |
DaxibotulinumtoxinA 40 Units
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
102
|
|
Overall Study
COMPLETED
|
182
|
93
|
|
Overall Study
NOT COMPLETED
|
19
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Baseline characteristics by cohort
| Measure |
DaxibotulinumtoxinA 40 Units
n=201 Participants
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=102 Participants
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
180 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
50.9 years
n=5 Participants
|
49.0 years
n=7 Participants
|
50.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black of African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
173 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
201 participants
n=5 Participants
|
102 participants
n=7 Participants
|
303 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Intent to treat population
Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments
Outcome measures
| Measure |
DaxibotulinumtoxinA
n=201 Participants
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=102 Participants
Biological/Vaccine: Placebo Intramuscular injection
Placebos: Intramuscular injection
|
|---|---|---|
|
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
|
73.6 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: 0-36 weeksPopulation: ITT population
The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
Outcome measures
| Measure |
DaxibotulinumtoxinA
n=201 Participants
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
Biological/Vaccine: Placebo Intramuscular injection
Placebos: Intramuscular injection
|
|---|---|---|
|
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
|
168 days
Interval 164.0 to 169.0
|
—
|
SECONDARY outcome
Timeframe: 0-36 weeksPopulation: ITT population
The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
Outcome measures
| Measure |
DaxibotulinumtoxinA
n=201 Participants
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
Biological/Vaccine: Placebo Intramuscular injection
Placebos: Intramuscular injection
|
|---|---|---|
|
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
|
194 days
Interval 173.0 to 196.0
|
—
|
Adverse Events
DaxibotulinumtoxinA 40 Units
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DaxibotulinumtoxinA 40 Units
n=201 participants at risk
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=102 participants at risk
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.50%
1/201 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/102 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Infections and infestations
Sepsis
|
0.50%
1/201 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.00%
0/102 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/201 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
0.98%
1/102 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
Other adverse events
| Measure |
DaxibotulinumtoxinA 40 Units
n=201 participants at risk
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=102 participants at risk
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
|---|---|---|
|
General disorders
Injection Site Pain
|
5.0%
10/201 • Number of events 10 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
3.9%
4/102 • Number of events 4 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
|
Nervous system disorders
Headache
|
9.5%
19/201 • Number of events 19 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
2.9%
3/102 • Number of events 3 • The adverse events were collected throughout the entire study, up to 36 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs.
|
Additional Information
Todd Gross, PhD, VP Data Science, Interim Head of Clinical Development
Revance Therapeutics, Inc.
Phone: 510-742-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee With respect to any proposed publication or disclosure of the results of the Study, the Study Center and Investigator shall submit to Revance a copy of the proposed publication or disclosure at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i) to provide Revance with the opportunity to review and comment on the contents thereof, and (ii) to identify any Confidential Information to be deleted from the proposed publication or disclosure.
- Publication restrictions are in place
Restriction type: OTHER