A Phase 2 interventional study of OnabotulinumtoxinA X and Placebo in Forehead Lines, sponsored by Allergan. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Allergan (part of AbbVie) · Phase 2, Interventional, and Treatment
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines.
Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States.
Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.
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:
Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
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.
Placebo will be injected into the forehead on Day 1.
Drug: Placebo
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Drug: OnabotulinumtoxinA X
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Drug: OnabotulinumtoxinA X
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Drug: OnabotulinumtoxinA X
Intramuscular Injection
Also known as: OnabotA X
Intramuscular Injection
Number of Participants With Adverse Events
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.
Time frame: Day 1 to Day 180
Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters
Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time frame: Day 1 to Day 180
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction.
Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.
Time frame: Day 1 to Day 30
| Milestone | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C |
|---|---|---|---|---|
| Started | 30 | 35 | 31 | 28 |
| Completed | 25 | 34 | 31 | 26 |
| Not completed | 5 | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 3 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 |
| Withdrew: Other | 2 | 0 | 0 | 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.
| Participants | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C |
|---|---|---|---|---|
| Number of Participants With Adverse Events | 10 | 12 | 18 | 13 |
Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.
| Participants | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C |
|---|---|---|---|---|
| Systolic Blood Pressure (mmHg): ≥ 160 and Increase of ≥ 20 | 0 | 1 | 1 | 1 |
| Systolic Blood Pressure (mmHg): ≤ 90 and Decrease of ≥ 20 | 0 | 1 | 1 | 0 |
| Diastolic Blood Pressure (mmHg): ≥ 100 and Increase of ≥ 15 | 1 | 0 | 0 | 0 |
| Diastolic Blood Pressure (mmHg): ≤ 50 and Decrease of ≥ 15 | 0 | 0 | 0 | 0 |
| Heart Rate (beats/min): ≥ 110 and Increase of ≥ 15 | 0 | 0 | 0 | 0 |
| Heart Rate (beats/min): ≤ 50 and Decrease of ≥ 15 | 0 | 0 | 0 | 0 |
| Temperature (C): ≥ 38.3 | 0 | 0 | 0 | 0 |
Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.
| percentage of participants | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C |
|---|---|---|---|---|
| Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction. | 58.6 (40.7 to 76.5) | 100 (100 to 100) | 96.8 (90.6 to 100) | 100 (100 to 100) |
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 190, 190, 191, and 189 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/30 (0%) | 1/30 (3.3%) | 4/30 (13.3%) |
| OnabotulinumtoxinA X Dose A | 0/35 (0%) | 0/35 (0%) | 5/35 (14.3%) |
| OnabotulinumtoxinA X Dose B | 0/31 (0%) | 0/31 (0%) | 10/31 (32.3%) |
| OnabotulinumtoxinA X Dose C | 0/28 (0%) | 0/28 (0%) | 9/28 (32.1%) |
| Event | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C |
|---|---|---|---|---|
| KIDNEY INFECTIONInfections and infestations | 1/30 | 0/35 | 0/31 | 0/28 |
| Event | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C |
|---|---|---|---|---|
| COVID-19Infections and infestations | 1/30 | 4/35 | 5/31 | 3/28 |
| EYELID PTOSISEye disorders | 0/30 | 0/35 | 0/31 | 3/28 |
| HEADACHENervous system disorders | 3/30 | 2/35 | 2/31 | 2/28 |
| INJECTION SITE BRUISINGGeneral disorders | 0/30 | 0/35 | 1/31 | 2/28 |
| INJECTION SITE PAINGeneral disorders | 1/30 | 0/35 | 2/31 | 2/28 |
| INJECTION SITE SWELLINGGeneral disorders | 1/30 | 1/35 | 2/31 | 2/28 |
| SINUSITISInfections and infestations | 0/30 | 0/35 | 0/31 | 2/28 |
| ASYMPTOMATIC COVID-19Infections and infestations | 0/30 | 1/35 | 2/31 | 0/28 |
| Age, Continuous(years) | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C | Total |
|---|---|---|---|---|---|
| Mean | 46.1 ± 12.33 | 43.7 ± 11.97 | 46.6 ± 11.82 | 50.5 ± 12.87 | 46.6 ± 12.32 |
| Age, Customized(Participants) | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C | Total |
|---|---|---|---|---|---|
| 18-25 | 1 | 2 | 2 | 0 | 5 |
| 26-40 | 9 | 11 | 7 | 8 | 35 |
| 41-55 | 11 | 16 | 13 | 9 | 49 |
| 56-64 | 8 | 5 | 9 | 7 | 29 |
| >=65 | 1 | 1 | 0 | 4 | 6 |
| Sex: Female, Male(Participants) | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C | Total |
|---|---|---|---|---|---|
| Female | 26 | 28 | 28 | 26 | 108 |
| Male | 4 | 7 | 3 | 2 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 4 | 6 | 19 |
| Not Hispanic or Latino | 24 | 32 | 27 | 22 | 105 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | OnabotulinumtoxinA X Dose A | OnabotulinumtoxinA X Dose B | OnabotulinumtoxinA X Dose C | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 0 | 2 |
| White | 30 | 34 | 28 | 26 | 118 |
| More than one race | 0 | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 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