Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jaw… (NCT04886544) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
Austria, Poland72 participantsStarted 2021-06-25
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection