Trial Outcomes & Findings for Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines (NCT NCT03736928)
NCT ID: NCT03736928
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 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
401 participants
Primary outcome timeframe
Month 1 after treatment
Results posted on
2022-08-26
Participant Flow
401 subjects were randomized, and 399 subjects received study product. Two (2) of the 401 randomized subjects did not receive study product due to hypertension that was identified pre-treatment.
Participant milestones
| Measure |
Dose Level 1 AbobotulinumtoxinA
Subjects randomized (4:1) to AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 2 AbobotulinumtoxinA
Subjects randomized (4:1) to AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 3 AbobotulinumtoxinA
Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 3: treatment of glabellar facial lines
|
Dose Level 4 AbobotulinumtoxinA
Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 4: treatment of glabellar facial lines
|
Placebo
Subjects randomized to placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
80
|
81
|
78
|
|
Overall Study
COMPLETED
|
73
|
78
|
75
|
76
|
67
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
5
|
5
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Baseline characteristics by cohort
| Measure |
Dose Level 1 AbobotulinumtoxinA
n=80 Participants
Subjects randomized (4:1) to dose level 1 AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 2 AbobotulinumtoxinA
n=80 Participants
Subjects randomized (4:1) to dose level 2 AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 3 AbobotulinumtoxinA
n=80 Participants
Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 3: treatment of glabellar facial lines
|
Dose Level 4 AbobotulinumtoxinA
n=81 Participants
Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 4: treatment of glabellar facial lines
|
Placebo
n=78 Participants
Subjects randomized to placebo
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 10.22 • n=4 Participants
|
47.6 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
48.4 years
STANDARD_DEVIATION 10.68 • n=10 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
352 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
348 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
80 participants
n=7 Participants
|
80 participants
n=5 Participants
|
81 participants
n=4 Participants
|
78 participants
n=21 Participants
|
399 participants
n=10 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
106 Participants
n=10 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
154 Participants
n=10 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
85 Participants
n=10 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
23 Participants
n=10 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 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Outcome measures
| Measure |
Dose Level 1 AbobotulinumtoxinA
n=80 Participants
Subjects randomized (4:1) to dose level 1 AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 2 AbobotulinumtoxinA
n=80 Participants
Subjects randomized (4:1) to dose level 2 AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 3 AbobotulinumtoxinA
n=80 Participants
Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 3: treatment of glabellar facial lines
|
Dose Level 4 AbobotulinumtoxinA
n=81 Participants
Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 4: treatment of glabellar facial lines
|
Placebo
n=78 Participants
Subjects randomized to placebo
|
|---|---|---|---|---|---|
|
Number of Composite Responders at Month 1
|
64 Participants
|
71 Participants
|
72 Participants
|
77 Participants
|
2 Participants
|
Adverse Events
Dose Level 1 AbobotulinumtoxinA
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2 AbobotulinumtoxinA
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 3 AbobotulinumtoxinA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 4 AbobotulinumtoxinA
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1 AbobotulinumtoxinA
n=80 participants at risk
Subjects randomized (4:1) to AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 2 AbobotulinumtoxinA
n=80 participants at risk
Subjects randomized (4:1) to AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 3 AbobotulinumtoxinA
n=80 participants at risk
Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 3: treatment of glabellar facial lines
|
Dose Level 4 AbobotulinumtoxinA
n=81 participants at risk
Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 4: treatment of glabellar facial lines
|
Placebo
n=78 participants at risk
Subjects randomized to placebo
|
|---|---|---|---|---|---|
|
Infections and infestations
Osteomyelitis
|
1.2%
1/80 • Number of events 1 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/81 • 36 Weeks
|
0.00%
0/78 • 36 Weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/80 • 36 Weeks
|
1.2%
1/80 • Number of events 1 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/81 • 36 Weeks
|
0.00%
0/78 • 36 Weeks
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/80 • 36 Weeks
|
1.2%
1/80 • Number of events 1 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/81 • 36 Weeks
|
0.00%
0/78 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/80 • 36 Weeks
|
1.2%
1/80 • Number of events 1 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/81 • 36 Weeks
|
0.00%
0/78 • 36 Weeks
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
1.2%
1/81 • Number of events 1 • 36 Weeks
|
0.00%
0/78 • 36 Weeks
|
|
Vascular disorders
Thrombosis
|
0.00%
0/80 • 36 Weeks
|
1.2%
1/80 • Number of events 1 • 36 Weeks
|
0.00%
0/80 • 36 Weeks
|
0.00%
0/81 • 36 Weeks
|
0.00%
0/78 • 36 Weeks
|
Other adverse events
| Measure |
Dose Level 1 AbobotulinumtoxinA
n=80 participants at risk
Subjects randomized (4:1) to AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 2 AbobotulinumtoxinA
n=80 participants at risk
Subjects randomized (4:1) to AbobotulinumtoxinA or placebo
AbobotulinumtoxinA dose 1/2: treatment of glabellar facial lines
placebo: treatment of glabellar facial lines
|
Dose Level 3 AbobotulinumtoxinA
n=80 participants at risk
Subjects randomized (4:1) to dose group 3 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 3: treatment of glabellar facial lines
|
Dose Level 4 AbobotulinumtoxinA
n=81 participants at risk
Subjects randomized (4:1) to dose group 4 AbobotulinumtoxinA or placebo
placebo: treatment of glabellar facial lines
AbobotulinumtoxinA dose 4: treatment of glabellar facial lines
|
Placebo
n=78 participants at risk
Subjects randomized to placebo
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.8%
3/80 • Number of events 3 • 36 Weeks
|
1.2%
1/80 • Number of events 1 • 36 Weeks
|
1.2%
1/80 • Number of events 1 • 36 Weeks
|
4.9%
4/81 • Number of events 4 • 36 Weeks
|
2.6%
2/78 • Number of events 2 • 36 Weeks
|
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