The Correction of Midface Volume Deficiency and/or Midface Contour Deficiency (NCT07359079) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
China356 participantsStarted 2025-03-19
Plain-language 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.
Who can participate
Age range26 Years
SexALL
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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 exclusion criteria will be ineligible for enrollment in the study:
1\. Subjects known to be allergic to hyaluronic acid products or to any component of the investigational medical device/control medical device; or subjects with a known history of severe allergies or anaphylactic shock.
* Subjects showing abnormal coagulation mechanism (activated partial thromboplastin time (APTT) \>1.5 times the upper limit of normal) during the screening period, or those who have received any thrombolytic agent, anticoagulant or antiplatelet drugs (such as warfarin and aspirin) within 2 weeks before the screening.
* Having tattoos, piercings, prominent facial hair, keloids, deformities, non-healed wounds, abscesses, granuloma, malignancies or precancerous lesions, malignant tumors, or skin mass of unknown natur…
What they're measuring
1
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).
Timeframe: 6 months
Trial details
NCT IDNCT07359079
SponsorChongqing Jinsaixing Medical Technology Co., Ltd