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

ArmDescriptionAssigned 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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center