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

Purpose

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.

Condition

Mid Face Volume Deficit

Eligibility

Eligible Ages: Between 22 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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.	Device: JUVÉDERM VOLUX XC Injections Device: JUVÉDERM VOLUMA XC Injections Device: JUVÉDERM VOLBELLA XC Injections Device: JUVÉDERM VOLLURE XC Injections Device: SKINVIVE by JUVÉDERM Injections Device: JUVÉDERM ULTRA XC Injections Device: JUVÉDERM ULTRA PLUS XC Injections

Recruiting Locations

More Details

NCT ID: NCT07186595
Status: Active, not recruiting
Sponsor: AbbVie

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.