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

NCT ID: NCT04687046

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-04

Study Completion Date

2022-02-28

Brief Summary

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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

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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.

Conditions

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Chin Retrusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort 1 JUVÉDERM VOLUX® with 3D Imaging

Treatment will be determined according to the physician's experience and Directions for Use. Cohort 1 will have follow-up on-site visits, including 3D imaging, at Months 1, 3, 6, and 12.

JUVÉDERM VOLUX®

Intervention Type DEVICE

JUVÉDERM VOLUX® injectable gel

Cohort 2 JUVÉDERM VOLUX®

Treatment will be determined according to the physician's experience and Directions for Use. Cohort 2 will have follow-up on-site visits at Months 1 and 3 and follow-up telephone calls at Months 6 and 12.

JUVÉDERM VOLUX®

Intervention Type DEVICE

JUVÉDERM VOLUX® injectable gel

Interventions

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JUVÉDERM VOLUX®

JUVÉDERM VOLUX® injectable gel

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

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Hainan Boao Super Hospital /ID# 235968

Qionghai, Hainan, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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1868-705-008

Identifier Type: -

Identifier Source: org_study_id

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