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

AbbVie

Status and phase

Enrolling

Phase 4

Conditions

Mid Face Volume Deficit

Treatments

Device: JUVÉDERM VOLUMA XC

Device: JUVÉDERM VOLUX XC

Device: JUVÉDERM VOLBELLA XC

Device: JUVÉDERM ULTRA XC

Device: SKINVIVE by JUVÉDERM

Device: JUVÉDERM ULTRA PLUS XC

Device: JUVÉDERM VOLLURE XC

Study type

Interventional

Funder types

Industry

Identifiers

NCT07186595

M25-631

Details and patient eligibility

About

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.

Enrollment

94 estimated patients

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

94 participants in 1 patient group

Open-Label JUVÉDERM

Experimental group

Description:

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.