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

NCT04886544 | Completed

• 1 other identifier: LG-HACL025
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Jaw Volume Deficit

Outcome Measures

Primary Outcomes (1)

• The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection

  The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1).

  26 weeks from baseline

Study Arms (2)

Test group

EXPERIMENTAL

Hyaluronic acid dermal filler at Week 0

Device: YVOIRE Y-Solution 720

Control group

NO INTERVENTION

Remain untreated until Week 26

Interventions

YVOIRE Y-Solution 720 DEVICE

Hyaluronic acid dermal filler

Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (3)

LG Chem investigational site 01

Vienna, Austria

Location

LG Chem investigational site 02

Vienna, Austria

Location

LG Chem investigational site 03

Krakow, Poland

Location

Study Officials

• Principal Investigator

  LG Chem Investigational site 01

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: June 25, 2021
• Primary Completion: May 11, 2022
• Study Completion: January 9, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

AU (2); PL (1)