Quantified Evaluation of Whole Face 8-points Supra-periosteum High Molecular Weight Hyaluronic Acid Injection in Asian

Обзор

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.

Первичные конечные точки

• Eyebrow Peak angle [Срок оценки: At Week 4, 12, and 24]
• Eyebrow Tail angle [Срок оценки: At Week 4, 12, and 24]
• Pupil-Eyebrow Peak angle [Срок оценки: At Week 4, 12, and 24]
• Canthus-Oral-Nasal angle [Срок оценки: At Week 4, 12, and 24]
• Eyebrow-Orbital length [Срок оценки: At Week 4, 12, and 24]
• Orbital-Upper Eyelid length [Срок оценки: At Week 4, 12, and 24]
• Vertical Palpebral Fissure length [Срок оценки: At Week 4, 12, and 24]
• Eyebrow-Iris length [Срок оценки: At Week 4, 12, and 24]
• Tragus-Oral length [Срок оценки: At Week 4, 12, and 24]
• Lower Facial Contouring length [Срок оценки: At Week 4, 12, and 24]

Вторичные конечные точки (1)

• Global Aesthetic Improvement Scale [Срок оценки: At Week 4, 12, and 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Subjects with epilepsy or underlying porphyria.
• When there is inactive disease (such as inflammation, infection or tumours) in or near the intended treatment site.
• Treatment procedure (e.g., bioresorbable fillers, laser/light therapies, botulinum toxin A injections, face lift, facial peels, excisional facial surgery, dermal photorejuvenation clinically significant oral or maxillofacial surgery, etc.) that may interfere with the treatment area or evaluation within 6 months prior to screening as determined by the Principal Investigator.
• The subject who received soft tissue augmentation as following at the investigational medical device injection site within 6 months prior to screening as determined by the Principal Investigator.
• The subject who received soft tissue augmentation near the injection site with any of the following at any time.
• Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with the judgment of the treatment effect.
• Subjects who participated in another clinical trial within 60 days prior to screening or plan to participate in another investigation during the course of this study.
• Subjects who plan to receive other wrinkle improvement treatment in the face during this trial.
• Subjects who are otherwise determined by the investigator as ineligible for this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06871592 · CMUH114-REC1-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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