Glabellar LinesPhase 2NCT05013424
A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
A Phase 2 study testing Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA in people with Glabellar Lines, run by Allergan at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Sep 2021to 7 Jul 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
- Women only
- 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.
- Participant has severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - Glabellar Lines (FWS-GL) at Baseline.
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 OnabotA 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
- History of facial nerve palsy
- Infection or dermatological condition at the site of study drug injection
- Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
- Any eyebrow or eyelid ptosis at baseline or Day 1 as determined by the investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Skin Research Institute LLC /ID# 227366
Coral Gables, Florida, 33146-1837
Advanced Research Associates - Glendale /ID# 227368
Glendale, Arizona, 85308
The Center for Dermatology Cosmetics & Laser Surgery /ID# 227369
Mount Kisco, New York, 10549-3028
Etre Cosmetic Dermatology and Laser Center /ID# 227365
New Orleans, Louisiana, 70130-4353
Austin Institute for Clinical Research /ID# 227367
Pflugerville, Texas, 78660
About this study
Official title: A Phase 2a Multicenter Open-label Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X in Subjects With Glabellar Lines
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.
Read more
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.
- Conditions
- Glabellar Lines
- Being tested
- Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA, Formulation C: OnabotulinumtoxinA
- Keywords
- Glabellar Lines, OnabotulinumtoxinA X, BOTOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation A: OnabotulinumtoxinADrug
Also called BOTOX, OnabotulinumtoxinA
Intramuscular Injection
Formulation B: OnabotulinumtoxinADrug
Also called BOTOX
Intramuscular Injection
Formulation C: OnabotulinumtoxinADrug
Also called BOTOX
Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Formulation A: OnabotulinumtoxinA | Experimental | Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. Receives: Drug: Formulation A: OnabotulinumtoxinA |
| Formulation B: OnabotulinumtoxinA | Experimental | Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. Receives: Drug: Formulation B: OnabotulinumtoxinA |
| Formulation C: OnabotulinumtoxinA | Experimental | Participants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. Receives: Drug: Formulation C: OnabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Sep 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 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
- Single group
- Masking
- None (open label)
- Enrolment
- 92 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
- NCT05013424
- Sponsor's protocol ID
- M21-324
- Status last verified
- Jun 2025
- First submitted
- 13 Aug 2021
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Multicenter Open-label Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X in Subjects With Glabellar Lines
- ClinicalTrials.gov ID
- NCT05013424
- Acronym / sponsor ID
- M21-324
- Conditions
- Glabellar Lines
- Keywords
- Glabellar Lines, OnabotulinumtoxinA X, BOTOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formulation A: OnabotulinumtoxinA | Experimental | Drug: Formulation A: OnabotulinumtoxinAParticipants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. |
| Formulation B: OnabotulinumtoxinA | Experimental | Drug: Formulation B: OnabotulinumtoxinAParticipants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. |
| Formulation C: OnabotulinumtoxinA | Experimental | Drug: Formulation C: OnabotulinumtoxinAParticipants will receive one dose of OnabotA X administered as 5 injections to the corrugator and procerus muscles on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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.
- Participant has severe GL at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale - Glabellar Lines (FWS-GL) at Baseline.
Key exclusion criteria (8 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 OnabotA X or interfere with the study evaluation, including:
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 |
|---|---|---|
| Formulation A: OnabotulinumtoxinAAlso: BOTOX, OnabotulinumtoxinAIntramuscular Injection | Drug | Formulation A: OnabotulinumtoxinA |
| Formulation B: OnabotulinumtoxinAAlso: BOTOXIntramuscular Injection | Drug | Formulation B: OnabotulinumtoxinA |
| Formulation C: OnabotulinumtoxinAAlso: BOTOXIntramuscular Injection | Drug | Formulation C: OnabotulinumtoxinA |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 180
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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
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
Upper Facial Lines, Glabellar Lines
Active, not recruitingPhase 1
A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
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
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
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
5 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 Formulation A: OnabotulinumtoxinA, Formulation B: OnabotulinumtoxinA and Formulation C: OnabotulinumtoxinA in people with Glabellar Lines, run by Allergan at 5 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 8 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 27 Jun 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1 to Day 180). 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 27 Jun 2025.