Trial Outcomes & Findings for Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines (NCT NCT05320393)
NCT ID: NCT05320393
Last Updated: 2024-09-04
Results Overview
Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Duration of effect for each subject will be based on number of days from baseline to the day that Glabellar Line Scale severity (Investigator Assessment) returns to baseline value, assessed every 30 days up to 365 days.
Results posted on
2024-09-04
Participant Flow
Participant milestones
| Measure |
Study Drug
40U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 40 units
|
OnabotulinumtoxinA
20U of OnabotulinumtoxinA
OnabotulinumtoxinA: One treatment of 20 units
|
PrabotulinumtoxinA-xvfs
20U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 20 units
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
53
|
|
Overall Study
COMPLETED
|
49
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
6
|
Reasons for withdrawal
| Measure |
Study Drug
40U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 40 units
|
OnabotulinumtoxinA
20U of OnabotulinumtoxinA
OnabotulinumtoxinA: One treatment of 20 units
|
PrabotulinumtoxinA-xvfs
20U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 20 units
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Moved; too much driving
|
0
|
0
|
2
|
|
Overall Study
Did not receive treatment
|
0
|
0
|
1
|
Baseline Characteristics
Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines
Baseline characteristics by cohort
| Measure |
Study Drug
n=51 Participants
40U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 40 units
|
OnabotulinumtoxinA
n=50 Participants
20U of OnabotulinumtoxinA
OnabotulinumtoxinA: One treatment of 20 units
|
PrabotulinumtoxinA-xvfs
n=53 Participants
20U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 20 units
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
47 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
50 participants
n=7 Participants
|
53 participants
n=5 Participants
|
154 participants
n=4 Participants
|
|
Participant Has a Prior history of botulinum toxin use
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Glabellar Line Score of Moderate at Maximum Frown by Investigator Assessment
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Glabellar Line Score of Moderate at Maximum Frown by Subject Assessment
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Glabellar Line Score of Severe at Maximum Frown by Investigator Assessment
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Glabellar Line Score of Severe at Maximum Frown by Subject Assessment
|
40 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Duration of effect for each subject will be based on number of days from baseline to the day that Glabellar Line Scale severity (Investigator Assessment) returns to baseline value, assessed every 30 days up to 365 days.Population: 152 participants comprised the modified intent to treat population; all 152 participants had at least one post-treatment assessment for the primary efficacy endpoint.
Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity.
Outcome measures
| Measure |
Study Drug
n=51 Participants
40U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 40 units
|
OnabotulinumtoxinA
n=50 Participants
20U of OnabotulinumtoxinA
OnabotulinumtoxinA: One treatment of 20 units
|
PrabotulinumtoxinA-xvfs
n=51 Participants
20U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 20 units
|
|---|---|---|---|
|
Duration of Effect Described by Kaplan-Meier Analysis
|
183 Days
Interval 153.0 to 211.0
|
148 Days
Interval 121.0 to 174.0
|
149 Days
Interval 130.0 to 174.0
|
Adverse Events
Study Drug
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OnabotulinumtoxinA
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PrabotulinumtoxinA-xvfs
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Drug
n=51 participants at risk
40U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 40 units
|
OnabotulinumtoxinA
n=50 participants at risk
20U of OnabotulinumtoxinA
OnabotulinumtoxinA: One treatment of 20 units
|
PrabotulinumtoxinA-xvfs
n=52 participants at risk；n=53 participants at risk
20U of PrabotulinumtoxinA-xvfs
PrabotulinumtoxinA-Xvfs: One treatment of 20 units
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
3.9%
2/51 • Number of events 2 • Adverse event data were collected over a period of up 12 months post treatment.
Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
|
4.0%
2/50 • Number of events 2 • Adverse event data were collected over a period of up 12 months post treatment.
Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
|
5.8%
3/52 • Number of events 4 • Adverse event data were collected over a period of up 12 months post treatment.
Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
|
|
Infections and infestations
COVID-19
|
0.00%
0/51 • Adverse event data were collected over a period of up 12 months post treatment.
Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
|
6.0%
3/50 • Number of events 3 • Adverse event data were collected over a period of up 12 months post treatment.
Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
|
0.00%
0/52 • Adverse event data were collected over a period of up 12 months post treatment.
Adverse events regardless of relationship or seriousness were collected at all study visits from the time of study enrollment until the follow-up or early termination visit period, and could be reported in response to a query, observed by the Investigator or site personnel, or reported spontaneously by the study participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the Study Sponsor. Any Investigator involved with this study is obligated to provide the Sponsor with complete test results and all data derived from the study.
- Publication restrictions are in place
Restriction type: OTHER