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Active, Not Recruiting

NCT Number: NCT07186595

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mid Face Volume Deficit

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kian Aesthetic Institute /ID# 277045, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JUVÉDERM VOLUX XC

Device

Injections

JUVÉDERM VOLUMA XC

Device

Injections

JUVÉDERM VOLBELLA XC

Device

Injections

JUVÉDERM VOLLURE XC

Device

Injections

SKINVIVE by JUVÉDERM

Device

Injections

JUVÉDERM ULTRA XC

Device

Injections

JUVÉDERM ULTRA PLUS XC

Device

Injections

Primary outcomes

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

    Time frame: Month 3

    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.

  2. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately Month 6

    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.

Secondary outcomes

  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)

    Time frame: Month 3

    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.

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

    Time frame: Month 3

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

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

    Time frame: Month 3

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

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

    Time frame: Month 3

    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.

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

    Time frame: Month 3

    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.

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

    Time frame: Month 3

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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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