Trial Outcomes & Findings for Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines (NCT NCT03004248)

Last Updated: 2022-07-13

Results Overview

Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2691 participants

Primary outcome timeframe

0-36 weeks

Results posted on

2022-07-13

Participant Flow

Outpatient, male or non-pregnant, non-nursing females, 18 years of age or older, 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

Participant milestones
Measure	DaxibotulinumtoxinA 40 Units Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
Overall Study STARTED	2691
Overall Study Received a Single Treatment	1809
Overall Study Received Two Treatments	314
Overall Study Received Three Treatments	568
Overall Study COMPLETED	2314
Overall Study NOT COMPLETED	377

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DaxibotulinumtoxinA 40 Units n=2691 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
Age, Continuous	50.0 years n=5 Participants
Sex: Female, Male Female	2383 Participants n=5 Participants
Sex: Female, Male Male	308 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	2407 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black of African American	129 Participants n=5 Participants
Race/Ethnicity, Customized Race · Others	82 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	73 Participants n=5 Participants
Region of Enrollment North America	2691 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-36 weeks

Population: Safety Evaluable Population

Outcome measures

Outcome measures
Measure	Treatment Cycle 1 n=2380 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 2 n=882 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 3 n=568 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
Incidence of Treatment Emergent Adverse Events (TEAE)	831 Participants	267 Participants	118 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Safety Evaluable 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

Outcome measures
Measure	Treatment Cycle 1 n=2380 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 2 n=882 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 3 n=568 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales	73.2 percentage of responders	76.8 percentage of responders	76.6 percentage of responders

SECONDARY outcome

Timeframe: 0-36 weeks per cycles 1 and 2

Population: Safety Evaluable Population

The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1 n=2380 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 2 n=882 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 3 Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	168.0 days Interval 167.0 to 168.0	169.0 days Interval 168.0 to 173.0	—

SECONDARY outcome

Timeframe: 0-36 weeks per Cycle 1 and 2

Population: Safety Evaluable Population

The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.

Outcome measures

Outcome measures
Measure	Treatment Cycle 1 n=2380 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 2 n=882 Participants Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection	Treatment Cycle 3 Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group	196 days Interval 196.0 to 197.0	197 days Interval 196.0 to 199.0	—

Adverse Events

Overall

Serious events: 29 serious events

Other events: 158 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Overall n=2691 participants at risk Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
Gastrointestinal disorders Abdominal pain	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Gastrointestinal disorders Gastrooesophageal reflux disease	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Gastrointestinal disorders Impaired gastric emptying	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Gastrointestinal disorders Intestinal obstruction	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Gastrointestinal disorders Pancreatis acute	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Hepatobiliary disorders Cholelithiasis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Infections and infestations Cellulitis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Infections and infestations Cholecystitis infective	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Infections and infestations Diverticulitis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Infections and infestations Gastroenteritis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Infections and infestations Influenza	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Infections and infestations Pelvic inflammatory disease	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Infections and infestations Sepsis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Injury, poisoning and procedural complications Humerus fracture	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Injury, poisoning and procedural complications Rib fracture	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Injury, poisoning and procedural complications Upper limb fracture	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Injury, poisoning and procedural complications Wrist fracture	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.07% 2/2691 • Number of events 2 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breat carcinoma	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Nervous system disorders Optic neuritis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Nervous system disorders Parasthesia	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Renal and urinary disorders Nephrolithiasis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Reproductive system and breast disorders Adenomyosis	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.04% 1/2691 • Number of events 1 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition

Other adverse events

Other adverse events
Measure	Overall n=2691 participants at risk Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection Botulinum Toxins, Type A: Intramuscular Injection
Nervous system disorders Headache	5.9% 158/2691 • Number of events 183 • 0-54 weeks Does not differ than the Clinicaltrials.gov definition

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