Jawline and Neck AppearancePhase 4AURANCT07794891
Study to Assess Participant Satisfaction After Jawline and Neck Treatment
A Phase 4 study testing OnabotulinumtoxinA, SKINVIVE and VOLUX in people with Jawline and Neck Appearance, run by AbbVie at 2 sites in Canada.
Trial summary
The goal of this study is to evaluate overall participant satisfaction with the jawline and neck. Participants will receive select Juvéderm products and onabotulinumtoxinA in the jaw area and neck per eligibility criteria. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Jawline and Neck Appearance
- What is being tested?
- OnabotulinumtoxinA, SKINVIVE and VOLUX
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Sep 2026to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or severe transverse neck lines based on investigator's live assessment
- Moderate or severe loss of jawline definition based on investigator's live assessment.
- Moderate or severe platysma prominence based on investigator's live assessment.
Who cannot join
- History of or current medical condition that may put the subject at increased medical risk with exposure to BOTOX, or any other condition that might interfere with neuromuscular function.
- History of or current symptoms of dysphagia.
- History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
- History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal or gram-positive bacterial proteins, lidocaine, HA products, any other excipients or constituents of the study drug, device, and/or other products in the same class.
- History of or tendency for keloid formation, hyperpigmentation, or hypertrophic scarring.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Sweat Clinics Of Canada /ID# 281845
Toronto, Ontario, M5R 3N8
- Recruiting
Humphrey & Beleznay Cosmetic Dermatology /ID# 282598
Vancouver, British Columbia, V5Z 4E1
About this study
Official title: A Prospective, Open-label Study to Evaluate Subject Satisfaction and Psychosocial Outcomes After Treatment of Jawline and Neck With BOTOX® Cosmetic and JUVÉDERM® Products
The goal of this study is to evaluate overall participant satisfaction with the jawline and neck.
Participants will receive select Juvéderm products and onabotulinumtoxinA in the jaw area and neck per eligibility criteria.
The study will measure changes in psychological function, satisfaction with lower face and jawline and skin appearance. Participants will attend visits during the study at a clinical site. The effects of the treatment will be checked by medical assessments, vital signs, physical examinations, checking for side effects, and completing questionnaires.
- Conditions
- Jawline and Neck Appearance
- Being tested
- OnabotulinumtoxinA, SKINVIVE, VOLUX, VOLUMA
- Keywords
- AURA Study, Jaw area and Neck Appearance, onabotulinumtoxinA, JUVÉDERM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Injection
SKINVIVEDevice
Injection
VOLUXDevice
Injection
VOLUMADevice
Injection
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM Products Plus OnabotulinumtoxinA | Experimental | Participants in the study will receive the products in the jaw area, chin, and neck. Receives: Drug: OnabotulinumtoxinA; Device: SKINVIVE; Device: VOLUX; Device: VOLUMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Response of Satisfied or Very Satisfied on Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction Follow-Up
The ANLFQ is a 5-point scale that assesses participant satisfaction. Response options range from Very satisfied to Very dissatisfied.
Measured: Day 104
Secondary outcomes (6)
Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Psychological Function
The FACE-Q Psychological Function scale assesses the psychological impact of facial appearance. The Rasch-transformed summary score ranges from worst to best.
Measured: Up to approximately 104 days
Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Satisfaction With Lower Face and Jawline
FACE-Q Satisfaction assesses participant satisfaction with the appearance of their lower face and jawline. The Rasch-transformed summary score ranges from worst to best.
Measured: Up to approximately 104 days
Change From Baseline in Participant's Rasch-transformed Score of the SKIN-Q - Skin Looks
SKIN-Q - Skin Looks assesses participant's satisfaction with how their skin looks. Rasch transformed scores ranges from worst to best.
Measured: Up to approximately 104 days
Change From Baseline in Participant's Allergan Facial Confidence Scale (AFCS) - Confidence (Treatment Area) Total Score
AFCS - Confidence (Treatment Area) is a questionnaire that assesses the participant's confidence in the appearance of the treatment area. 4-point response option ranges from Very Confident to Not at all confident.
Measured: Up to approximately 104 days
Percentage of Participants With Response of Improved or Much Improved on Investigator Global Aesthetic Improvement Scale (GAIS)
GAIS is a clinician-rated 5-point scale that assesses of overall aesthetic improvement compared to baseline. Scores range from "Much improved" to "Much worse".
Measured: Up to approximately 104 days
Percentage of Participants With Response of Satisfied or Very Satisfied (or Agree or Definitely Agree) on Allergan Facial Satisfaction Scale (AFSS) - Natural Look and Feel
AFSS assesses participant satisfaction. Scores range from "Very satisfied" to" Very dissatisfied".
Measured: Up to approximately 104 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start9 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jawline and Neck AppearanceStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794891
- Sponsor's protocol ID
- M26-109
- Acronym
- AURA
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Study to Evaluate Subject Satisfaction and Psychosocial Outcomes After Treatment of Jawline and Neck With BOTOX® Cosmetic and JUVÉDERM® Products
- ClinicalTrials.gov ID
- NCT07794891
- Acronym / sponsor ID
- AURA / M26-109
- Conditions
- Jawline and Neck Appearance
- Keywords
- AURA Study, Jaw area and Neck Appearance, onabotulinumtoxinA, JUVÉDERM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate overall participant satisfaction with the jawline and neck.
Participants will receive select Juvéderm products and onabotulinumtoxinA in the jaw area and neck per eligibility criteria.
The study will measure changes in psychological function, satisfaction with lower face and jawline and skin appearance. Participants will attend visits during the study at a clinical site. The effects of the treatment will be checked by medical assessments, vital signs, physical examinations, checking for side effects, and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM Products Plus OnabotulinumtoxinA | Experimental | Drug: OnabotulinumtoxinA, Device: SKINVIVE, Device: VOLUX, Device: VOLUMAParticipants in the study will receive the products in the jaw area, chin, and neck. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate or severe transverse neck lines based on investigator's live assessment
- Moderate or severe loss of jawline definition based on investigator's live assessment.
- Moderate or severe platysma prominence based on investigator's live assessment.
Key exclusion criteria (5 listed)
- History of or current medical condition that may put the subject at increased medical risk with exposure to BOTOX, or any other condition that might interfere with neuromuscular function.
- History of or current symptoms of dysphagia.
- History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
- History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal or gram-positive bacterial proteins, lidocaine, HA products, any other excipients or constituents of the study drug, device, and/or other products in the same class.
- History of or tendency for keloid formation, hyperpigmentation, or hypertrophic scarring.
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 |
|---|---|---|
| OnabotulinumtoxinAInjection | Drug | JUVÉDERM Products Plus OnabotulinumtoxinA |
| SKINVIVEInjection | Device | JUVÉDERM Products Plus OnabotulinumtoxinA |
| VOLUXInjection | Device | JUVÉDERM Products Plus OnabotulinumtoxinA |
| VOLUMAInjection | Device | JUVÉDERM Products Plus OnabotulinumtoxinA |
Primary outcome
Percentage of Participants With Response of Satisfied or Very Satisfied on Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction Follow-Up
Time frame: Day 104
The ANLFQ is a 5-point scale that assesses participant satisfaction. Response options range from Very satisfied to Very dissatisfied.
6 secondary outcomes
Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Psychological Function
Time frame: Up to approximately 104 days
Change From Baseline in Participant's Rasch-transformed Score of the FACE-Q Satisfaction With Lower Face and Jawline
Time frame: Up to approximately 104 days
Change From Baseline in Participant's Rasch-transformed Score of the SKIN-Q - Skin Looks
Time frame: Up to approximately 104 days
Change From Baseline in Participant's Allergan Facial Confidence Scale (AFCS) - Confidence (Treatment Area) Total Score
Time frame: Up to approximately 104 days
Percentage of Participants With Response of Improved or Much Improved on Investigator Global Aesthetic Improvement Scale (GAIS)
Time frame: Up to approximately 104 days
Percentage of Participants With Response of Satisfied or Very Satisfied (or Agree or Definitely Agree) on Allergan Facial Satisfaction Scale (AFSS) - Natural Look and Feel
Time frame: Up to approximately 104 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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.
ABBVIE INC. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OnabotulinumtoxinA, SKINVIVE and VOLUX in people with Jawline and Neck Appearance, run by AbbVie at 2 sites in Canada.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Response of Satisfied or Very Satisfied on Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction Follow-Up (time frame: Day 104). 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 8 Oct 2026.