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: Active, not recruiting; 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: 75 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)

---

75 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.

Treatment:

Device: JUVÉDERM ULTRA PLUS XC

Device: JUVÉDERM VOLLURE XC

Device: SKINVIVE by JUVÉDERM

Device: JUVÉDERM ULTRA XC

Device: JUVÉDERM VOLBELLA XC

Device: JUVÉDERM VOLUX XC

Device: JUVÉDERM VOLUMA XC