Status:
COMPLETED
Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
Lead Sponsor:
LG Chem
Conditions:
Jaw Volume Deficit
Eligibility:
All Genders
18-75 years
Phase:
NA
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
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04886544
Start Date
June 25 2021
End Date
January 9 2023
Last Update
May 12 2023
Active Locations (3)
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1
LG Chem investigational site 01
Vienna, Austria
2
LG Chem investigational site 02
Vienna, Austria
3
LG Chem investigational site 03
Krakow, Poland