Facial ContouringPhase 4US HarmonyNCT06783621
A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products
A Phase 4 study testing OnabotulinumtoxinA, JUVÉDERM and CoolSculpting Elite System in people with Facial Contouring, run by AbbVie at 10 sites in United States.
Trial summary
A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Facial Contouring
- What is being tested?
- OnabotulinumtoxinA, JUVÉDERM and CoolSculpting Elite System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Jan 2025to 20 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Applies to All Participants:
- Must meet at least 1 of the following criteria for BOTOX UFL treatment per investigator's assessment:
- Moderate or severe on Allergan Glabellar Line Severity Scale at maximum furrow
- Moderate or severe on Forehead Line Severity Scale at maximum brow elevation and Moderate or Severe on Allergan Glabellar Line Severity Scale at maximum furrow
- Moderate or severe on Lateral Canthal Line Severity Scale at maximum contraction (identical severity on both sides)
- Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:
Show all 16Show fewer
- Moderate or severe on Allergan Loss of Jawline Definition Scale
- Moderate or severe on Allergan Chin Retrusion Scale
- Moderate, significant, or severe on Midface Volume Deficit Scale
- Moderate or severe on Nasolabial Fold Severity Scale
- Moderate or severe for both eyes on Allergan Infraorbital Hollows Scale
- Minimal, mild, or moderate on 5-point Allergan Lip Fullness Scale
- Moderate or severe on Allergan Cheek Smoothness Scale
- Minimal, moderate, or severe on Allergan Temple Hollowing Scale
- Applies only to participants who will be treated for submental fullness:
- Moderate or severe on the Clinician-reported Submental Fat Rating Scale (for KYBELLA treatment) or Moderate, severe, or extreme (For CoolSculpting Elite treatment) per investigator's assessment.
Who cannot join
- History of medical condition that may put the subject at increased medical risk with exposure to OnabotulinumtoxinA, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
- History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal protein, lidocaine (or any amide-based anesthetics), HA products, any other excipients or constituents of the study drug, device, SkinMedica products and/or other products in the same class.
- Marked facial asymmetry (e.g., asymmetry in eyebrow and/or eyelid position, asymmetrical smile or significant asymmetry in the lower face), facial nerve palsy, 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.
- Previous plastic surgery, tissue grafting, permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), or tissue augmentation with silicone, fat, or other permanent dermal fillers of the face and/or neck or plan to undergo any of these procedures at any time during the study.
- Prior exposure to botulinum toxin of any serotype to any part of the body within 6 months prior to screening.
- Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening.
- Prior treatment with energy-based devices (e.g., intense pulsed light, Clear + Brilliant®, monopolar radiofrequency, microfocused ultrasound, etc.,) or other noninvasive fat reduction procedure and/or skin-tightening laser treatments in the face or neck within 6 months prior to screening.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
SkinDC /ID# 270411
Arlington, Virginia, 22209
Bellaire Dermatology Associates /ID# 270429
Bellaire, Texas, 77401
Boyd /Id# 270509
Birmingham, Michigan, 48009-6301
Skin Research Institute LLC /ID# 270410
Coral Gables, Florida, 33146-1837
DelRicht Research - Prytania Street - New Orleans 308 /ID# 270425
New Orleans, Louisiana, 70115
Luxurgery /ID# 270430
New York, New York, 10021
Marcus Facial Plastic Surgery /ID# 270408
Redondo Beach, California, 90277
Integrated Aesthetics /ID# 270399
Spring, Texas, 77388
Pacific Clinical Innovations /ID# 270414
Vista, California, 92083-6030
Center for Dermatology and Dermatologic Surgery /ID# 270390
Washington D.C., District of Columbia, 20037-1495
About this study
Official title: US HARMONY in DIVERSITY: A Prospective, Open-label Study to Evaluate Subject Satisfaction With the Overall Face and Neck Appearance After Combined Treatment
A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population.
- Conditions
- Facial Contouring
- Being tested
- OnabotulinumtoxinA, JUVÉDERM, CoolSculpting Elite System, SkinMedica Products, KYBELLA
- Keywords
- Facial Contouring, OnabotulinumtoxinA, JUVEDERM Products, KYBELLA, CoolSculpting Elite, SkinMedica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Intramuscular Injections
JUVÉDERMDevice
Also called VOLUX XC, VOLUMA XC, VOLLURE XC, VOLBELLA XC
Injections
CoolSculpting Elite SystemDevice
CoolSculpting Elite Applicator
SkinMedica ProductsOther
Skincare Product
KYBELLADrug
Injections
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Open-Label Combination Treatments | Experimental | All participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria). Receives: Drug: OnabotulinumtoxinA; Device: JUVÉDERM; Device: CoolSculpting Elite System; Other: SkinMedica Products; Drug: KYBELLA |
| Cohort 2: Open-Label Combination Treatments | Experimental | All participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria). Receives: Drug: OnabotulinumtoxinA; Device: JUVÉDERM; Other: SkinMedica Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit
The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face.
Measured: Up to approximately 284 days
Secondary outcomes (3)
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit
The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function.
Measured: Up to approximately 284 days
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit
The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function.
Measured: Up to approximately 284 days
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit
The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality.
Measured: Up to approximately 284 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start16 Jan 2025
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ContouringStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
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
- NCT06783621
- Sponsor's protocol ID
- M24-704
- Acronym
- US Harmony
- Status last verified
- May 2026
- First submitted
- 15 Jan 2025
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US HARMONY in DIVERSITY: A Prospective, Open-label Study to Evaluate Subject Satisfaction With the Overall Face and Neck Appearance After Combined Treatment
- ClinicalTrials.gov ID
- NCT06783621
- Acronym / sponsor ID
- US Harmony / M24-704
- Conditions
- Facial Contouring
- Keywords
- Facial Contouring, OnabotulinumtoxinA, JUVEDERM Products, KYBELLA, CoolSculpting Elite, SkinMedica
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 20 Jan 2025 (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.
A study to evaluate overall participant satisfaction of face and neck appearance after treatment with onabotulinumtoxinA, JUVÉDERM® products, KYBELLA, CoolSculpting Elite, and select SkinMedica products in a diverse population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Open-Label Combination Treatments | Experimental | Drug: OnabotulinumtoxinA, Device: JUVÉDERM, Device: CoolSculpting Elite System, Other: SkinMedica Products, Drug: KYBELLAAll participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria). |
| Cohort 2: Open-Label Combination Treatments | Experimental | Drug: OnabotulinumtoxinA, Device: JUVÉDERM, Other: SkinMedica ProductsAll participants in the study will receive treatment with onabotulinumtoxinA and JUVÉDERM (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria). |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Must meet at least 1 of the following criteria for BOTOX UFL treatment per investigator's assessment:
- Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:
- Moderate or severe on the Clinician-reported Submental Fat Rating Scale (for KYBELLA treatment) or Moderate, severe, or extreme (For CoolSculpting Elite treatment) per investigator's assessment.
Key exclusion criteria (7 listed)
- History of medical condition that may put the subject at increased medical risk with exposure to OnabotulinumtoxinA, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
- History of hypersensitivity or allergy to any botulinum toxin serotype, Streptococcal protein, lidocaine (or any amide-based anesthetics), HA products, any other excipients or constituents of the study drug, device, SkinMedica products and/or other products in the same class.
- Marked facial asymmetry (e.g., asymmetry in eyebrow and/or eyelid position, asymmetrical smile or significant asymmetry in the lower face), facial nerve palsy, 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.
- Previous plastic surgery, tissue grafting, permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), or tissue augmentation with silicone, fat, or other permanent dermal fillers of the face and/or neck or plan to undergo any of these procedures at any time during the study.
- Prior exposure to botulinum toxin of any serotype to any part of the body within 6 months prior to screening.
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 |
|---|---|---|
| OnabotulinumtoxinAIntramuscular Injections | Drug | Cohort 1: Open-Label Combination Treatments, Cohort 2: Open-Label Combination Treatments |
| JUVÉDERMAlso: VOLUX XC, VOLUMA XC, VOLLURE XC, VOLBELLA XCInjections | Device | Cohort 1: Open-Label Combination Treatments, Cohort 2: Open-Label Combination Treatments |
| CoolSculpting Elite SystemCoolSculpting Elite Applicator | Device | Cohort 1: Open-Label Combination Treatments |
| SkinMedica ProductsSkincare Product | Other | Cohort 1: Open-Label Combination Treatments, Cohort 2: Open-Label Combination Treatments |
| KYBELLAInjections | Drug | Cohort 1: Open-Label Combination Treatments |
Primary outcome
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit
Time frame: Up to approximately 284 days
The FACE-Q Satisfaction with Facial Appearance is a validated questionnaire that asks participants to report their level of satisfaction with the appearance of their face.
3 secondary outcomes
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale at the Final Visit
Time frame: Up to approximately 284 days
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit
Time frame: Up to approximately 284 days
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale at the Final Visit
Time frame: Up to approximately 284 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
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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.
ABBVIE INC. study director
AbbVie
10 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, JUVÉDERM and CoolSculpting Elite System in people with Facial Contouring, run by AbbVie at 10 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 16 inclusion and 7 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Satisfaction with Facial Appearance Scale at the Final Visit (time frame: Up to approximately 284 days). 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 22 May 2026.