Trial Outcomes & Findings for Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands (NCT NCT04080882)
NCT ID: NCT04080882
Last Updated: 2022-08-26
Results Overview
A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Month 1 after treatment
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Placebo
placebo injected into platysma bands
Placebo: Treatment of platysmal bands
|
AbobotulinumtoxinA Dose 1
AbobotulinumtoxinA dose 1 injected into platysma bands
AbobotulinumtoxinA dose 1: Treatment of platysmal bands
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
60
|
|
Overall Study
COMPLETED
|
18
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands
Baseline characteristics by cohort
| Measure |
Total
n=80 Participants
Total of all reporting groups
|
Placebo
n=20 Participants
placebo injected into platysma bands
Placebo: Treatment of platysmal bands
|
AbobotulinumtoxinA Dose 1
n=60 Participants
AbobotulinumtoxinA dose 1 injected into platysma bands
AbobotulinumtoxinA dose 1: Treatment of platysmal bands
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 7.74 • n=7 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
17 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
18 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
20 participants
n=5 Participants
|
60 participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
26 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
30 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
19 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
3 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Month 1 after treatmentPopulation: Due to business decision study did not proceed to enroll dose 2 or dose 3.
A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA).
Outcome measures
| Measure |
Placebo
n=20 Participants
placebo injected into platysma bands
Placebo: Treatment of platysmal bands
|
AbobotulinumtoxinA Dose 1
n=60 Participants
AbobotulinumtoxinA dose 1 injected into platysma bands
AbobotulinumtoxinA dose 1: Treatment of platysmal bands
|
|---|---|---|
|
Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo
|
3 Participants
|
36 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AbobotulinumtoxinA Dose 1
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
placebo injected into platysma bands
Placebo: Treatment of platysmal bands
|
AbobotulinumtoxinA Dose 1
n=60 participants at risk
AbobotulinumtoxinA dose 1 injected into platysma bands
AbobotulinumtoxinA dose 1: Treatment of platysmal bands
|
|---|---|---|
|
Eye disorders
Diplopia
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Eye disorders
Dry Eye
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
5.0%
3/60 • Number of events 3 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Gastrointestinal disorders
Dental Caries
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
General disorders
Injection site bruising
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
8.3%
5/60 • Number of events 5 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
General disorders
Injection site heamorrhage
|
0.00%
0/20 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
5.0%
3/60 • Number of events 3 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
General disorders
Injection site swelling
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Infections and infestations
Viral upper respiratory tract infectinon
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
3.3%
2/60 • Number of events 3 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
1.7%
1/60 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
0.00%
0/60 • 5 months
Due to business decision study did not proceed to enroll dose 2 or dose 3.
|
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