Trial Outcomes & Findings for Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines (NCT NCT03960957)
NCT ID: NCT03960957
Last Updated: 2022-08-26
Results Overview
Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
301 participants
Primary outcome timeframe
Month 1 after treatment
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Experimental
AbobotulinumtoxinA
AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
|
Placebo
Placebo: Treatment of glabellar facial lines with placebo
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
77
|
|
Overall Study
COMPLETED
|
216
|
71
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Baseline characteristics by cohort
| Measure |
Experimental
n=224 Participants
AbobotulinumtoxinA
AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
|
Placebo
n=77 Participants
Placebo: Treatment of glabellar facial lines with placebo
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 11.86 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
205 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
224 participants
n=5 Participants
|
77 participants
n=7 Participants
|
301 participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
59 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
107 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
45 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1 after treatmentComposite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Outcome measures
| Measure |
Experimental
n=224 Participants
AbobotulinumtoxinA
AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
|
Placebo
n=77 Participants
Placebo: Treatment of glabellar facial lines with placebo
|
|---|---|---|
|
Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo
|
142 Participants
|
0 Participants
|
Adverse Events
Experimental
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=223 participants at risk
AbobotulinumtoxinA
AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
|
Placebo
n=77 participants at risk
Placebo: Treatment of glabellar facial lines with placebo
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Worsening knee pain
|
0.45%
1/223 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
0.00%
0/77 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
Infections and infestations
Acute diverticulitis
|
0.45%
1/223 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
0.00%
0/77 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
Cardiac disorders
Long QT syndrome
|
0.45%
1/223 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
0.00%
0/77 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
Gastrointestinal disorders
Worsening of hemorrhoids
|
0.45%
1/223 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
0.00%
0/77 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
Other adverse events
| Measure |
Experimental
n=223 participants at risk
AbobotulinumtoxinA
AbobotulinumtoxinA: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
|
Placebo
n=77 participants at risk
Placebo: Treatment of glabellar facial lines with placebo
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
8.5%
19/223 • Number of events 19 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
3.9%
3/77 • Number of events 3 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
Nervous system disorders
Migraine
|
0.45%
1/223 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
0.00%
0/77 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
Eye disorders
Eyelid ptosis
|
1.3%
3/223 • Number of events 3 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
0.00%
0/77 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
General disorders
injection site pain
|
0.45%
1/223 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
2.6%
2/77 • Number of events 2 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
General disorders
Injection site reaction
|
0.45%
1/223 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
0.00%
0/77 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
General disorders
Injection site discomfort
|
0.00%
0/223 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
1.3%
1/77 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
0.00%
0/223 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
1.3%
1/77 • Number of events 1 • 24 weeks
While 224 subjects were randomized to study product (i.e. ITT population), 223 subjects were administered the study product (i.e. safety population).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
- Publication restrictions are in place
Restriction type: OTHER