Phase 2
N=328
A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
Glabellar Lines
Bottom Line
View on ClinicalTrials.gov: NCT05100199 ↗Enrolled (actual)
328
Serious AEs
1.2%
Results posted
Sep 2025
Primary outcome: Primary: Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale. — 17.8; 95.6; 98.9; 98.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OnabotulinumtoxinA X (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale. |
17.8; 95.6; 98.9; 98.0 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
23; 34; 30; 44; 7; 13 | — |
| SECONDARY Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale. |
6.7; 90.0; 93.5; 95.0 | — |
| SECONDARY Percentage of Participants With Achievement of Improvement Per the Facial Lines Satisfaction Questionnaire Impact Domain, Among Subjects With Baseline Scores of 14 Points or Greater. |
42.2; 65.6; 71.7; 73.3 | — |
| SECONDARY Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5. |
4.4; 80.0; 78.3; 87.1 | — |
Summary
This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.
Eligibility Criteria
Inclusion Criteria
- Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.
- Participant has moderate or severe GL at maximum frown.
Exclusion Criteria
- History of known immunization to any botulinum toxin serotype.
- History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
- Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:
- Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
- Facial nerve palsy.
- Infection or dermatological condition at the site of study drug injection.
Data sourced from ClinicalTrials.gov (NCT05100199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.