Facial aging is a complex process characterized by skin atrophy, subcutaneous fat loss, and alterations in bone structure. The loss of volume, primarily due to bone resorption and loss of adjacent fat volume from different facial regions, leads to soft tissue flattening. Hyaluronic acid (HA) is a widely used biomaterial in clinical practice, known for its excellent tissue compatibility, low risk, and safety. Previous research and clinical practice have demonstrated that HA for facial lifting can help restore facial fullness, elasticity, and promote a more youthful appearance. Dermatologist previously utilized the supra-periosteum lift technique in high molecular weight hyaluronic acid injection. It was found that the material properties of high molecular weight hyaluronic acid not only made it suitable for filling but also provided lifting support, resulting in improvements in cheek fullness and facial aging. However, there has been no detailed quantitative study on the efficacy of high molecular weight hyaluronic acid for facial lifting.
To further investigate this effect, the investigators plan to conduct a prospective, open-label clinical trial. The investigators will recruit 25 adult and use an 8-point supra-periosteum facial lifting technique to inject high molecular weight hyaluronic acid. Assessments will be conducted preoperatively, postoperatively, and 4 weeks, 12 weeks and 24 weeks postoperatively to analyze the treatment efficacy. The eight injection points will be located at the brow peak, brow tail, pterion, lateral canthus, zygomatic ligament, mid-cheek, nasolabial fold, and mentalis. The investigators will use evaluation forms with four angles and six lengths, as well as the Global Aesthetic Improvement Scale, to quantify the degree of improvement in facial aging. Additionally, The investigators will use a satisfaction survey to understand subjects' perceptions of postoperative lifting effects and overall improvement satisfaction. The investigators hypothesized this study to improve facial aging in Asian patients and provide long-lasting effects.
Men and women aged between 20 and 60.
Subjects who are capable of understanding and comply with the study procedures, instructions, and visit schedule.
Subjects who voluntarily decide to participate in the entire course of the trial and provide written consent in the Informed Consent Form.
Subjects with a history of anaphylaxis, allergy hyaluronic acid products, or any component of devices.
Subjects with autoimmune diseases/ received immune system and Subjects with diabetes mellitus.
Subjects with a history of a hypertrophic scar.
Pregnant or breastfeeding women.
Men and women aged between 20 and 60.
Case-only
Prospective
Not listed
Eyebrow Peak angle
The vertices of the Eyebrow Peak angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Eyebrow Tail angle
The vertices of the Eyebrow Tail angles lie at the static point eyebrow head, measured against a horizontal line parallel to the ground.
Pupil-Eyebrow Peak angle
The Pupil-Eyebrow Peak angle is then measured between this line and another line connecting nasal to eyebrow peak.
Canthus-Oral-Nasal angle
The Canthus-Oral-Nasal angle is measured between a line connecting oral commissure to nasal and a line connecting oral commissure to lateral canthus.
Global Aesthetic Improvement Scale
Subjects with Global Aesthetic Improvement Scale (GAIS) from baseline after injection will be evaluated by a subjects who will judge the severity score. Score 0 (worse)\~4 (Very much improved)
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Chang Chang Cheng
Lead sponsor
China Medical University Hospital
Sponsor institution
Yung Shin Pharm. Ind. Co., Ltd.
Collaborator
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