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

NCT ID: NCT07186595

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mid Face Volume Deficit

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-Label JUVÉDERM

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.

Group Type EXPERIMENTAL

JUVÉDERM VOLUX XC

Intervention Type DEVICE

Injections

JUVÉDERM VOLUMA XC

Intervention Type DEVICE

Injections

JUVÉDERM VOLBELLA XC

Intervention Type DEVICE

Injections

JUVÉDERM VOLLURE XC

Intervention Type DEVICE

Injections

SKINVIVE by JUVÉDERM

Intervention Type DEVICE

Injections

JUVÉDERM ULTRA XC

Intervention Type DEVICE

Injections

JUVÉDERM ULTRA PLUS XC

Intervention Type DEVICE

Injections

Interventions

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JUVÉDERM VOLUX XC

Injections

Intervention Type DEVICE

JUVÉDERM VOLUMA XC

Injections

Intervention Type DEVICE

JUVÉDERM VOLBELLA XC

Injections

Intervention Type DEVICE

JUVÉDERM VOLLURE XC

Injections

Intervention Type DEVICE

SKINVIVE by JUVÉDERM

Injections

Intervention Type DEVICE

JUVÉDERM ULTRA XC

Injections

Intervention Type DEVICE

JUVÉDERM ULTRA PLUS XC

Injections

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Kian Aesthetic Institute /ID# 277045

Los Angeles, California, United States

Site Status RECRUITING

Pacific Clinical Innovations /ID# 277026

Vista, California, United States

Site Status RECRUITING

Skin Research Institute LLC /ID# 277038

Coral Gables, Florida, United States

Site Status RECRUITING

Monarch Plastic Surgery and Skin Renewal Center /ID# 278182

Atlanta, Georgia, United States

Site Status RECRUITING

SkinDC /ID# 277062

Arlington, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Related Links

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Other Identifiers

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M25-631

Identifier Type: -

Identifier Source: org_study_id