A Phase 3 interventional study of JUVÉDERM VOLUX® in Chin Retrusion, sponsored by Allergan. Completed at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.
Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator.
Device: JUVÉDERM VOLUX®
No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.
Device: JUVÉDERM VOLUX®
JUVÉDERM VOLUX® injectable gel
Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion.
Time frame: Change from Baseline to Week 24
China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24
The CACRS is a validated 5-point ordinal scale developed by Allergan to grade the severity of chin retrusion. The scale ranges from 0=none to 4=severe.
Time frame: Week 24
Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24
The subject will assess satisfaction using the 10 items on the Satisfaction with Chin FACE-Q.
Time frame: Week 24
Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24
The GAIS is a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time frame: Week 24
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
The number of patients who experienced one or more TEAEs
Time frame: Up to week 52
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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