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Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

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LG Chem

Status

Completed

Conditions

Jaw Volume Deficit

Treatments

Device: YVOIRE Y-Solution 720

Study type

Interventional

Funder types

Industry

Identifiers

NCT04886544
LG-HACL025

Details and patient eligibility

About

A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

Full description

This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.

Enrollment

72 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female adults 18 - 75 years of age (inclusive)
  • 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
  • want a filler injection procedure for the replacement of volume loss in the jawlines

Exclusion criteria

  • have an active or infective skin disease
  • have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
  • have a tattoo or excessive facial hair in the evaluation area
  • have received permanent facial implants
  • have undergone semi-permanent filler within 24 months
  • have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months
  • have streptococcal disease
  • have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid
  • have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products
  • have history of bleeding disorder
  • have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion
  • have known malignant tumors or cancerous or precancerous lesion
  • positive pregnancy test indicating pregnancy
  • active COVID-19 infection and suspected COVID-19 infection within the past 14 days

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups

Test group
Experimental group
Description:
Hyaluronic acid dermal filler at Week 0
Treatment:
Device: YVOIRE Y-Solution 720
Control group
No Intervention group
Description:
Remain untreated until Week 26

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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