The purpose is to evaluate the efficacy and confirm the safety of Rejeunesse Contour® with Lidocaine compared to Juvederm® Voluma® with Lidocaine for the temporary improvement of mid-face volume (including the cheekbone area, the anterior-medial cheek, and the area below the cheekbone). The investigational medical device will be administered a total of once during the entire clinical trial period (or up to twice if additional treatment is required). After the administration, photographs of the application site and evaluations using the Mid-Face Volume Deficit Scale (MFVDS) will be conducted at 4 weeks, 12 weeks, 24 weeks, and 48 weeks. Satisfaction with mid-face volume improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS). Additionally, changes in concomitant medications/treatments and adverse events will be reviewed in comparison to the previous visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
89
Crosslinked hyaluronic acid (HA) 22 mg/mL + 0.3% lidocaine hydrochloride.
Crosslinked hyaluronic acid (HA) 20 mg/mL + 0.3% lidocaine hydrochloride.
Chung-Ang University Hospital
Soeul, South Korea
Percentage improvement in mid-face volume
Percentage improvement in mid-face volume at Weeks 24 after the final administration of the investigational medical device, as assessed by independent photo evaluators compared with baseline
Time frame: at Weeks 24 after the final administration
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