Trial Outcomes & Findings for A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines (NCT NCT05013424)
NCT ID: NCT05013424
Last Updated: 2025-06-27
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Day 1 to Day 180
Results posted on
2025-06-27
Participant Flow
Participant milestones
| Measure |
Formulation A: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation B: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation B: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation C: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation C: OnabotulinumtoxinA: Intramuscular Injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
31
|
|
Overall Study
COMPLETED
|
28
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Formulation A: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation B: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation B: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation C: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation C: OnabotulinumtoxinA: Intramuscular Injection
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
Baseline characteristics by cohort
| Measure |
Formulation A: OnabotulinumtoxinA
n=29 Participants
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation B: OnabotulinumtoxinA
n=31 Participants
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation B: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation C: OnabotulinumtoxinA
n=31 Participants
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation C: OnabotulinumtoxinA: Intramuscular Injection
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 10.69 • n=4 Participants
|
|
Age, Customized
18-25 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Age, Customized
26-40 years
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Age, Customized
41-55 years
|
12 participants
n=5 Participants
|
18 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Age, Customized
56-64 years
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 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
|
PRIMARY outcome
Timeframe: Day 1 to Day 180Population: All participants who received at least 1 dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
Outcome measures
| Measure |
Formulation A: OnabotulinumtoxinA
n=29 Participants
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation B: OnabotulinumtoxinA
n=31 Participants
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation B: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation C: OnabotulinumtoxinA
n=31 Participants
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation C: OnabotulinumtoxinA: Intramuscular Injection
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-Emergent Adverse Events (TEAE)
|
7 Participants
|
15 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to Study Treatment
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to Study Procedure
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to Study Drug
|
2 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Formulation A: OnabotulinumtoxinA
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Formulation B: OnabotulinumtoxinA
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Formulation C: OnabotulinumtoxinA
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Formulation A: OnabotulinumtoxinA
n=29 participants at risk
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation B: OnabotulinumtoxinA
n=32 participants at risk
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation C: OnabotulinumtoxinA
n=31 participants at risk
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
|---|---|---|---|
|
Vascular disorders
HYPERTENSIVE URGENCY
|
0.00%
0/29 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
Other adverse events
| Measure |
Formulation A: OnabotulinumtoxinA
n=29 participants at risk
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation B: OnabotulinumtoxinA
n=32 participants at risk
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
Formulation C: OnabotulinumtoxinA
n=31 participants at risk
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Formulation A: OnabotulinumtoxinA: Intramuscular Injection
|
|---|---|---|---|
|
General disorders
INJECTION SITE PRURITUS
|
6.9%
2/29 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
|
Infections and infestations
COVID-19
|
3.4%
1/29 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
18.8%
6/32 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
19.4%
6/31 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.9%
2/29 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
9.4%
3/32 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
9.7%
3/31 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/29 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
9.4%
3/32 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 188, 184.5 and 190 days for Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER