Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04687046
NCT04687046CompletedNot Applicable

A Real-World Evidence Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults

Allergan1 site in 1 country90 target enrollmentStarted: February 4, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Allergan
Enrollment
90
Locations
1
Primary Endpoint
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.

Detailed Description

There will be 30 participants selected who undergo 3D imaging before and after JUVÉDERM VOLUX® treatment for digital analysis assessments. Up to 90 participants enrolled either prospectively prior to JUVÉDERM VOLUX® treatment or retrospectively after JUVÉDERM VOLUX® treatment.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital.

Exclusion Criteria

  • •History of hypersensitivity to lidocaine,HA, or Streptococcal protein
  • •History of tendency to develop hypertrophic scarring
  • •Untreated epilepsy or porphyria
  • •Current cutaneous inflammatory or infectious processes (eg, acne, herpes) in the treatment area
  • •Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
  • •Permanent filler, semi-permanent filler, or fat injected in the treatment area
  • •Temporary filler, other than VOLUX, injected in the treatment area within 12 months before enrollment
  • •Females who self-report current pregnancy or breastfeeding

Outcomes

Primary Outcomes

Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle

Time Frame: Baseline, Month 3

Secondary Outcomes

  • Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS(Month 3)
  • The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits(Month 1, 3, 6, and 12)
  • Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)(Month 3)
  • The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits(Month 1, 3, 6, and 12)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline DefinitionJawline Definition
NCT03712137Allergan206
Terminated
Not Applicable
Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple HollowingTemple Hollowing
NCT03166618Allergan1
Completed
Phase 4
A Study to Evaluate the Effect of Juvederm Volift With Lidocaine on Aging Hands in Participants Age 35 and OlderSkin DepressionsSkin ElasticitySkin Laxity
NCT04390581Allergan75
Completed
Not Applicable
JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian NoseAsian Nose Enhancement
NCT01846039Allergan29
Completed
Not Applicable
A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using CannulaAge-related Volume Deficit in the Mid-face
NCT03438266Allergan66