Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 2/3/2019 |
Start Date: | November 12, 2018 |
End Date: | February 26, 2021 |
Contact: | Clinical Trials Registry Team |
Email: | IR-CTRegistration@Allergan.com |
Phone: | 877-277-8566 |
A Multicenter, Evaluator-blinded, Randomized, Parallelgroup, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel
for restoring jawline definition
for restoring jawline definition
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
We found this trial at
20
sites
Mount Kisco, New York 10549
Phone: 914-241-3003
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Houston, Texas 77056
Phone: 713-985-0210
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Washington, District of Columbia 20037
Phone: 202-955-5757
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