Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

Allergan

Status and phase: Completed; Phase 3

Conditions: Jawline Definition

Treatments: Device: VOLUX XC; Other: No-treatment control

Study type: Interventional

Funder types: Industry

Identifiers

NCT03712137

V25L-002

Details and patient eligibility

About

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition

Enrollment: 206 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3
• Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition
• Written Informed Consent (IC) has been obtained

Exclusion criteria

• Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
• Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study
• Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study
• Has received deoxycholic acid treatment in the submental region in the last 6 months
• Has active autoimmune disease
• Females who are pregnant, nursing, or planning a pregnancy during the course of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

VOLUX XC

Experimental group

Description:

Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.

Treatment:

Device: VOLUX XC

No-treatment control

Experimental group

Description:

No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.

Treatment:

Other: No-treatment control