NCT07186595

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
3mo left

Started Sep 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2025Aug 2026

First Submitted

Initial submission to the registry

September 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

September 16, 2025

Last Update Submit

February 20, 2026

Conditions

Mid Face Volume Deficit

Keywords

Mid Face Volume DeficitJUVÉDERM VOLUX XCJUVÉDERM VOLUMA XCJUVÉDERM VOLLURE XCJUVÉDERM VOLBELLA XCSKINVIVE by JUVÉDERMJUVÉDERM ULTRA XCJUVÉDERM ULTRA PLUS XC

Outcome Measures

Primary Outcomes (2)

  • 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.

    Month 3

  • 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.

    Up to approximately Month 6

Secondary Outcomes (6)

  • 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)

    Month 3

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

    Month 3

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

    Month 3

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

    Month 3

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

    Month 3

  • +1 more secondary outcomes

Study Arms (1)

Open-Label JUVÉDERM

EXPERIMENTAL

Participants 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.

Device: JUVÉDERM VOLUX XCDevice: JUVÉDERM VOLUMA XCDevice: JUVÉDERM VOLBELLA XCDevice: JUVÉDERM VOLLURE XCDevice: SKINVIVE by JUVÉDERMDevice: JUVÉDERM ULTRA XCDevice: JUVÉDERM ULTRA PLUS XC

Interventions

JUVÉDERM VOLUX XCDEVICE

Injections

Open-Label JUVÉDERM
JUVÉDERM VOLUMA XCDEVICE

Injections

Open-Label JUVÉDERM
JUVÉDERM VOLBELLA XCDEVICE

Injections

Open-Label JUVÉDERM
JUVÉDERM VOLLURE XCDEVICE

Injections

Open-Label JUVÉDERM
SKINVIVE by JUVÉDERMDEVICE

Injections

Open-Label JUVÉDERM
JUVÉDERM ULTRA XCDEVICE

Injections

Open-Label JUVÉDERM
JUVÉDERM ULTRA PLUS XCDEVICE

Injections

Open-Label JUVÉDERM

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kian Aesthetic Institute /ID# 277045

Los Angeles, California, 90025, United States

Location

West Dermatology La Jolla /ID# 277034

San Diego, California, 92121, United States

Location

Pacific Clinical Innovations /ID# 277026

Vista, California, 92083, United States

Location

Skin Research Institute LLC /ID# 277038

Coral Gables, Florida, 33146-1837, United States

Location

Monarch Plastic Surgery and Skin Renewal Center /ID# 278182

Atlanta, Georgia, 30328, United States

Location

Advanced Dermatology - Lincolnshire /ID# 277036

Lincolnshire, Illinois, 60069, United States

Location

H&H Research, LLC /ID# 277084

Metairie, Louisiana, 70001, United States

Location

DelRicht Research - New Orleans 308 /ID# 277039

New Orleans, Louisiana, 70115, United States

Location

Bellaire Dermatology Associates /ID# 278180

Bellaire, Texas, 77401, United States

Location

SkinDC /ID# 277062

Arlington, Virginia, 22209, United States

Location

Related Links

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 22, 2025

Study Start

September 25, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access Criteria
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
More information

Locations

US(10)