Glabellar LinesPhase 2NCT05100199
A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
A Phase 2 study testing OnabotulinumtoxinA X in people with Glabellar Lines, run by Allergan at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- OnabotulinumtoxinA X
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 18 sitesUnited States
- Study dates
- 6 Oct 2021to 2 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543
Austin, Texas, 78746-4720
Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542
Boca Raton, Florida, 33431-6465
Aesthetic Solutions /ID# 230716
Chapel Hill, North Carolina, 27517-9901
Aventiv Research Dublin /ID# 232546
Dublin, Ohio, 43016
Advanced Research Associates - Glendale /ID# 230418
Glendale, Arizona, 85308
Westside Aesthetics /ID# 230305
Los Angeles, California, 90025-1708
Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693
Metairie, Louisiana, 70006
Baumann Cosmetic and Research Institute /ID# 232545
Miami, Florida, 33137-3254
Etre Cosmetic Dermatology and Laser Center /ID# 230437
New Orleans, Louisiana, 70130-4353
Laser & Skin Surgery Center of New York /ID# 230683
New York, New York, 10016-4974
The Eye Research Foundation /ID# 232544
Newport Beach, California, 92663-3637
Skin Search of Rochester Inc. /ID# 242540
Rochester, New York, 14623
The Research Center at The Maas Clinic /ID# 230685
San Francisco, California, 94115-1809
Premier Clinical Research /ID# 230682
Spokane, Washington, 99202
SLUCare Cosmetic Dermatology /ID# 230333
St Louis, Missouri, 63122-3379
Center for Dermatology and Dermatologic Surgery /ID# 230684
Washington D.C., District of Columbia, 20037-1445
Research Institute of the Southeast, LLC /ID# 230436
West Palm Beach, Florida, 33401-2712
Wilmington Dermatology Center /ID# 242544
Wilmington, North Carolina, 28403
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines
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.
- Conditions
- Glabellar Lines
- Being tested
- OnabotulinumtoxinA X, Placebo
- Keywords
- OnabotulinumtoxinA X, BOTOX, Glabellar Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA XDrug
Injection
PlaceboDrug
Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be injected into the Glabellar Complex on Day 1. Receives: Drug: Placebo |
| OnabotulinumtoxinA X Dose A | Experimental | OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1. Receives: Drug: OnabotulinumtoxinA X |
| OnabotulinumtoxinA X Dose B | Experimental | OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1. Receives: Drug: OnabotulinumtoxinA X |
| OnabotulinumtoxinA X Dose C | Experimental | OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1. Receives: Drug: OnabotulinumtoxinA X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Measured: Day 1 to Day 30
Percentage of Participants With Adverse Events (AEs)
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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of 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 study drug.
Measured: Day 1 to Day 270
Secondary outcomes (3)
Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale.
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Measured: Day 1 to Day 30
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.
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Domain scores are calculated as the mean of transformed item scores on a 0 (low impact) to 100 (highest negative impact) scale.
Measured: Day 1 to Day 30
Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5.
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
A score of 100 represents the best score (very satisfied) and a score of 0 represent the worst score (very dissatisfied) on the satisfaction domain or satisfaction single items.
Measured: Day 1 to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start6 Oct 2021
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100199
- Sponsor's protocol ID
- 2042-201-008
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2021
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05100199
- Acronym / sponsor ID
- 2042-201-008
- Conditions
- Glabellar Lines
- Keywords
- OnabotulinumtoxinA X, BOTOX, Glabellar Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be injected into the Glabellar Complex on Day 1. |
| OnabotulinumtoxinA X Dose A | Experimental | Drug: OnabotulinumtoxinA XOnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1. |
| OnabotulinumtoxinA X Dose B | Experimental | Drug: OnabotulinumtoxinA XOnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1. |
| OnabotulinumtoxinA X Dose C | Experimental | Drug: OnabotulinumtoxinA XOnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinA XInjection | Drug | OnabotulinumtoxinA X Dose A, OnabotulinumtoxinA X Dose B, OnabotulinumtoxinA X Dose C |
| PlaceboInjection | Drug | Placebo |
Primary outcome
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.
Time frame: Day 1 to Day 30
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Percentage of Participants With Adverse Events (AEs)
Time frame: Day 1 to Day 270
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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of 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 study drug.
3 secondary outcomes
Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale.
Time frame: Day 1 to Day 30
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.
Time frame: Day 1 to Day 30
Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5.
Time frame: Day 1 to Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
Related trials for Glabellar Lines
Active, not recruitingPhase 1
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RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
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Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
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RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OnabotulinumtoxinA X in people with Glabellar Lines, run by Allergan at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale. (time frame: Day 1 to Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.