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Mid Face Volume DeficitPhase 4NCT07186595

A Study to Evaluate the Safety and Effectiveness of JUVÉDERM Products in Adult Participants for the Change of Their Overall Facial Appearance

A Phase 4 study testing JUVÉDERM VOLUX XC, JUVÉDERM VOLUMA XC and JUVÉDERM VOLBELLA XC in people with Mid Face Volume Deficit, run by AbbVie at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of JUVÉDERM products in adults seeking improvement in facial volume and/or skin quality. Read more about this study

Who is it for?
Ages 22 to 65 years
Conditions the study is for
Mid Face Volume Deficit
What is being tested?
JUVÉDERM VOLUX XC, JUVÉDERM VOLUMA XC and JUVÉDERM VOLBELLA XC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
10 sitesUnited States
Study dates
25 Sep 2025to 8 Jul 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

  • Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment:
  • Minimal, moderate, or severe on Allergan Temple Hollowing Scale (ATHS)
  • Moderate or severe for both eyes on Allergan Infraorbital Hollow Scale (AIHS)
  • Moderate or severe on Allergan Cheek Smoothness Scale (ACSS)
  • Moderate, significant, or severe on Mid-face Volume Deficit Scale (MFVDS)
  • Moderate or severe on Nasolabial Fold Severity Scale (NLFSS)
Show all 10Show fewer
  • Minimal, mild, or moderate on Allergan Lip Fullness Scale 2 (ALFS2)
  • Moderate or severe on Allergan Chin Retrusion Scale (ACRS)
  • Moderate or severe on Allergan Loss of Jawline Definition Scale (ALJDS)
  • Must be in good health as determined by subject's medical history, physical examination, and vital sign measurements.

Who cannot join

  • Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening.
  • Excessively loose skin in the face and/or neck.
  • Tendency to develop hypertrophic scarring and/or keloid scarring.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • SkinDC /ID# 277062

    Arlington, Virginia, 22209

  • Monarch Plastic Surgery and Skin Renewal Center /ID# 278182

    Atlanta, Georgia, 30328

  • Bellaire Dermatology Associates /ID# 278180

    Bellaire, Texas, 77401

  • Skin Research Institute LLC /ID# 277038

    Coral Gables, Florida, 33146-1837

  • Advanced Dermatology - Lincolnshire /ID# 277036

    Lincolnshire, Illinois, 60069

  • Kian Aesthetic Institute /ID# 277045

    Los Angeles, California, 90025

  • H and H Research LLC /ID# 277084

    Metairie, Louisiana, 70001

  • Delricht Research - Prytania Street - New Orleans /ID# 277039

    New Orleans, Louisiana, 70115

  • West Dermatology La Jolla /ID# 277034

    San Diego, California, 92121

  • Pacific Clinical Innovations /ID# 277026

    Vista, California, 92083

Other trials in United States

About this study

Official title: A Prospective, Open-Label Study to Evaluate Subject Satisfaction With Overall Facial Appearance After Treatment With JUVÉDERM® Products in Medical Weight Loss (MWL) Subjects

The purpose of this study is to evaluate the safety and effectiveness of JUVÉDERM products in adults seeking improvement in facial volume and/or skin quality.

Being tested
JUVÉDERM VOLUX XC, JUVÉDERM VOLUMA XC, JUVÉDERM VOLBELLA XC, JUVÉDERM VOLLURE XC, SKINVIVE by JUVÉDERM
Keywords
Mid Face Volume Deficit, JUVÉDERM VOLUX XC, JUVÉDERM VOLUMA XC, JUVÉDERM VOLLURE XC, JUVÉDERM VOLBELLA XC, SKINVIVE by JUVÉDERM, JUVÉDERM ULTRA XC, JUVÉDERM ULTRA PLUS XC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JUVÉDERM VOLUX XCDevice

    Injections

  • JUVÉDERM VOLUMA XCDevice

    Injections

  • JUVÉDERM VOLBELLA XCDevice

    Injections

  • JUVÉDERM VOLLURE XCDevice

    Injections

  • SKINVIVE by JUVÉDERMDevice

    Injections

  • JUVÉDERM ULTRA XCDevice

    Injections

  • JUVÉDERM ULTRA PLUS XCDevice

    Injections

Study groups in NCT07186595
Study groupRoleWhat they receive
Open-Label JUVÉDERMExperimentalParticipants will receive at least 2 JUVÉDERM products for at least 3 indications (specific products and indications will be at the discretion of the investigator and per participant eligibility criteria) at Treatment Visit 1.
Receives: Device: JUVÉDERM VOLUX XC; Device: JUVÉDERM VOLUMA XC; Device: JUVÉDERM VOLBELLA XC; Device: JUVÉDERM VOLLURE XC; Device: SKINVIVE by JUVÉDERM; Device: JUVÉDERM ULTRA XC; Device: JUVÉDERM ULTRA PLUS XC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q™ Satisfaction with Facial Appearance Scale

    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: Month 3

  2. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately Month 6

Secondary outcomes (6)

  1. Percentage of Participants Achieving "Responder" Status of Global Aesthetic Improvement on Facial Appearance Based on the Principal Investigator's Assessment Using the Global Aesthetic Improvement Scale (GAIS)

    The GAIS uses a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. A responder is defined as "improved" or "much improved" in the overall aesthetics assessment in the periorbital area.

    Measured: Month 3

  2. Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Psychological Function Scale

    The FACE-Q Psychological Function is a validated questionnaire that asks participants to report their level of satisfaction with psychological function.

    Measured: Month 3

  3. Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale

    The FACE-Q Social Function Scale is a validated questionnaire that asks participants to report their level of satisfaction with social function.

    Measured: Month 3

  4. Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Feels Scale

    The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin feels.

    Measured: Month 3

  5. Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Looks Scale

    The SKIN-Q Scale is a validated questionnaire that asks participants to report their level of satisfaction with skin quality related to how the skin looks.

    Measured: Month 3

  6. Percentage of Participants Achieving "Responder" Status Based on Participant Responses on the Natural Look Satisfaction Scale (NLSS) Assessment

    The NLSS is an 8-item scale that measures satisfaction with various attributes that are associated with natural looking results following aesthetic treatment.

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start25 Sep 2025
  3. Primary completion8 Jul 2026
  4. Study completion8 Jul 2026

Resources

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186595
Sponsor's protocol ID
M25-631
Status last verified
Aug 2026
First submitted
16 Sep 2025
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing JUVÉDERM VOLUX XC, JUVÉDERM VOLUMA XC and JUVÉDERM VOLBELLA XC in people with Mid Face Volume Deficit, 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 10 inclusion and 3 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 10 Aug 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 (time frame: Month 3). 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?

On the ClinicalTrials.gov record for NCT07186595.

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 10 Aug 2026.

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