This study is clinical investigation for evaluating safety and efficacy of JTM102 on temporary correction of mid-face volume deficiency
This study is Multicenter, Randomized, Subject \& Independent Evaluator-blind, Split-face, Medical Device Pivotal study to evaluate the efficacy and safety of injection with JTM102 as compared to Juvederm VOLUMA with Lidocaine for temporary restoring the mid-face volume
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
149
Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 03.%
Sodium Hyaluronate 20mg/ml Lidocaine Hydrochloride 0.3%
Chungang University Hospital
Seoul, South Korea
Improvement in midface volume
Facial volume deficiency was graded using 6-point Facial Midvolume Measuring Scale with higher scores indicating greater severity of gauntness. The proportion of subjects whose score decreased from baseline, as assessed by independent photographic evaluators, was calculated.
Time frame: 24 weeks after final application of the investigational medical device
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