the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
Conditions
Brief summary
The objective of this clinical trial is to evaluate the efficacy and safety of PEGDE-crosslinked hyaluronic acid hydrogels for the correction of midface volume deficiency and/or midface contour deficiency, on the premise of ensuring the safety of the subjects and maintaining the scientific integrity of the clinical trial.
Interventions
PROCEDUREStimulate
the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
BIOLOGICALRestylane Volyme
the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
Sponsors
Chongqing Jinsaixing Medical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Subject-Blinded, Evaluator-Blinded
Eligibility
Sex/Gender
ALL
Age
26 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 26 (including 26 years old), male or female; * Subjects willing to correct midface volume deficiency and/or midface contour deficiency; * According to the assessment by the blinded evaluators, subjects must have mild to severe midface volume deficiency and/or midface contour deficiency on each side (MMVS grade of 2 to 4). It is not required for both sides to have the same MMVS grade, but the difference in MMVS grade between the two sides must be ≤ 1 grade; * Subjects are able to understand the objective of the study, voluntarily participate in the study and are willing to sign a written ICF.
Exclusion criteria
* Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness rate of improvement for midface volume deficiency and/or midface contour deficiency at 6 months after the last injection (as assessed by the blinded evaluators). | 6 months |
Countries
China
Outcome results
None listed