A Phase 2 interventional study of Formulation A: OnabotulinumtoxinA and Formulation B: OnabotulinumtoxinA in Glabellar Lines, sponsored by Allergan. Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Allergan (part of AbbVie) · Phase 2, Interventional, and Treatment
Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X formulation is in treating adult participants with GL .
OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the safety of a single dose of 3 different formulations of OnabotA X (A, B \& C; each with varying amounts of the standard excipients in the formulation) in adult subjects with moderate to severe GL. Around 90 participants will be enrolled in the study in approximately 5 sites in the United States.
Participants will receive one dose of OnabotA X administered as 5 injections on Day 1.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted after Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotA X or interfere with the study evaluation, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Drug: Formulation A: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Drug: Formulation B: OnabotulinumtoxinA
Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1.
Drug: Formulation C: OnabotulinumtoxinA
Intramuscular Injection
Also known as: BOTOX, OnabotulinumtoxinA
Intramuscular Injection
Also known as: BOTOX
Intramuscular Injection
Also known as: BOTOX
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: Day 1 to Day 180
| Milestone | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA |
|---|---|---|---|
| Started | 29 | 32 | 31 |
| Completed | 28 | 30 | 30 |
| Not completed | 1 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
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.
| Participants | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA |
|---|---|---|---|
| Treatment-Emergent Adverse Events (TEAE) | 7 | 15 | 9 |
| TEAE Related to Study Treatment | 2 | 5 | 1 |
| TEAE Related to Study Procedure | 0 | 4 | 1 |
| TEAE Related to Study Drug | 2 | 3 | 1 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Formulation A: OnabotulinumtoxinA | 0/29 (0%) | 0/29 (0%) | 4/29 (13.8%) |
| Formulation B: OnabotulinumtoxinA | 0/32 (0%) | 1/32 (3.1%) | 9/32 (28.1%) |
| Formulation C: OnabotulinumtoxinA | 0/31 (0%) | 0/31 (0%) | 7/31 (22.6%) |
| Event | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA |
|---|---|---|---|
| HYPERTENSIVE URGENCYVascular disorders | 0/29 | 1/32 | 0/31 |
| Event | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA |
|---|---|---|---|
| COVID-19Infections and infestations | 1/29 | 6/32 | 6/31 |
| URINARY TRACT INFECTIONInfections and infestations | 2/29 | 3/32 | 3/31 |
| HEADACHENervous system disorders | 0/29 | 3/32 | 0/31 |
| INJECTION SITE PRURITUSGeneral disorders | 2/29 | 0/32 | 0/31 |
All randomized subjects who received at least 1 dose of study drug.
| Age, Continuous(years) | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA | Total |
|---|---|---|---|---|
| Mean | 52.2 ± 11.47 | 45.7 ± 9.97 | 49.4 ± 9.96 | 49.0 ± 10.69 |
| Age, Customized(participants) | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA | Total |
|---|---|---|---|---|
| 18-25 years | 1 | 2 | 0 | 3 |
| 26-40 years | 3 | 6 | 7 | 16 |
| 41-55 years | 12 | 18 | 15 | 45 |
| 56-64 years | 10 | 3 | 8 | 21 |
| >=65 years | 3 | 2 | 1 | 6 |
| Sex: Female, Male(Participants) | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA | Total |
|---|---|---|---|---|
| Female | 29 | 31 | 31 | 91 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 8 | 6 | 19 |
| Not Hispanic or Latino | 24 | 23 | 25 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Formulation A: OnabotulinumtoxinA | Formulation B: OnabotulinumtoxinA | Formulation C: OnabotulinumtoxinA | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 | 4 |
| White | 27 | 31 | 28 | 86 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A