Phase 3
Completed N=206
Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Jawline Definition
Source: ClinicalTrials.gov NCT03712137 ↗
Enrolled (actual)
206
Serious AEs
7.5%
Results posted
Jan 2023
Primary outcomePrimary: Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS) — 38.0; 69.0 percentage of participants — p=0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS) |
38.0; 69.0 | 0.0001 sig |
| SECONDARY Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) |
13; 130 | — |
| SECONDARY Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS) |
129 | — |
| SECONDARY Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score |
45.9 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03712137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.