Trial Outcomes & Findings for Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (NCT NCT03014635)
NCT ID: NCT03014635
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
306 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
|
204
|
102
|
|
Overall Study
COMPLETED
|
191
|
93
|
|
Overall Study
NOT COMPLETED
|
13
|
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=204 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=306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
189 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Continuous
|
49.6 years
n=99 Participants
|
50.5 years
n=107 Participants
|
49.9 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
270 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
180 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
272 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
North America
|
204 participants
n=99 Participants
|
102 participants
n=107 Participants
|
306 participants
n=206 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 40 Units
n=204 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
|
|---|---|---|
|
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
|
74.0 percentage of responders
|
1.0 percentage of responders
|
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 40 Units
n=204 Participants
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
|---|---|---|
|
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
|
167 days
Interval 142.0 to 168.0
|
—
|
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 40 Units
n=204 Participants
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
|---|---|---|
|
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
|
182 days
Interval 169.0 to 196.0
|
—
|
Adverse Events
DaxibotulinumtoxinA 40 Units
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DaxibotulinumtoxinA 40 Units
n=205 participants at risk
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=101 participants at risk
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.49%
1/205 • Number of events 1 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
0.00%
0/101 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma recurrent
|
0.00%
0/205 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
0.99%
1/101 • Number of events 1 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyosarcoma
|
0.49%
1/205 • Number of events 1 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
0.00%
0/101 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
Other adverse events
| Measure |
DaxibotulinumtoxinA 40 Units
n=205 participants at risk
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=101 participants at risk
Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.8%
18/205 • Number of events 21 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
2.0%
2/101 • Number of events 2 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
12/205 • Number of events 16 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
3.0%
3/101 • Number of events 4 • Adverse events were collected throughout the entire study, up to 36 weeks
Adverse event incidence rates were based on the Safety population which includes 205 subjects exposed to DaxibotulinumtoxinA 40 units and 101 subjects who received placebo. Note 1 subject randomized to placebo was treated with DaxibotulinumtoxinA.
|
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