Safety and Efficacy Study of Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- WSRS improvement ratio at week 24 post-injection
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it aims to answer are:
- The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
- The differences of Global Aesthetic Improvement Scale (GAIS) after the injection.
- The subjective satisfaction of treatment.
- Safety Indicators of which incidences on the day of the injection or after the injection.
Participants will be self-controlled and randomized for same period
- received both trial product and control product at the same time.
- re-visited on week 2, 4, 12, 24, 36, and 52 after injection.
Researchers will compare if the test product is non-inferiority to Q-Med Restylane.
详细描述
The purpose of this study is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. A single-centre, non-inferior, randomized, double-blind trial with a control group was conducted in this study. Every subject received the trial product and control product injections at the same time. It was planned to recruit 95 subjects with the 10% dropout rate. This clinical trial is accordance with the "Good Clinical Practice (GCP) issued by the Department of Health and ISO14155-1：2003 Clinical investigation of medical devices for human subjects - Part 1: General Requirements and carried out according to the trial proposal approved by the Tri-Service General Hospital Human Subjects Review Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are aged 30-65 years old of both sexes.
- •Subjects who are willing to undergo WSRS therapy.
- •The WSRS baseline measurement should be 3-4 points and the left and right side should be in symmetry.
- •The facial skin is healthy, without any disease that possibly interferes with skin aging status assessment.
- •The subject is willing to avoid undergoing other cosmetic treatment and surgery, including Botox injection.
排除标准
- •Women subjects who are pregnant, breastfeeding, planning to become pregnant, and not willing to take contraception during the trial period.
- •Those who are emotionally unstable or suffering from a mental disease.
- •Those who have severe skin disease, inflammation, or related symptoms such as infections, psoriasis, herpes, and the like.
- •Those who have undergone cosmetic treatment or surgery prior to the trial:
- •Those who have undergone laser treatment or dermabrasion within the past 12 months.
- •Those who have undergone chemical peels treatment within the last three months.
- •Those who have undergone facial wrinkle augmentation surgery such as Botox injections within the past 12 months.
- •Those with silicone in their body or material that cannot be absorbed by the body (permanent filling agent).
- •Those who have undergone facial surgery or filing agent implants in the nasolabial fold area within the past 24 months.
- •Those who have a scar or localized infection in the nasolabial fold area.
- •Those with connective tissue diseases.
- •Those with diabetes or systemic disease that cannot be controlled.
- •Those suffering from human immunodeficiency syndrome.
- •Those suffering from immunity related disorder or have had immune system degradation in the past.
- •Those with a scar-prone constitution, prone to scar formation or hypertrophic scars.
- •Those who have joined other clinical trials such ass medical device related and other similar trials within the past six months.
- •Those with a medical history of cosmetic filling agent allergy, any type of hyaluronic acid implants, or drugs (such as antibiotics, antihistamine, non-steroidal anti-inflammatory analgesics), or those with a medical history of local anesthetic allergy.
- •Patients undergoing anticoagulant treatment, those who have a medical history of coagulation defects, or those taking Chinese medicine for promoting blood circulation.
- •Those whose medication and medical conditions are deemed unfit for inclusion in the research based on the judgment of the researcher.
- •Those who are unable to comply with re-visit schedule or are unwell to sign the informed consent.
结局指标
主要结局
WSRS improvement ratio at week 24 post-injection
时间窗: Baseline and week 24
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. A positive value indicated "effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.
次要结局
- Difference of WSRS score(Baseline to week 24 post-injection)
- GAIS score(Baseline to week 24 post-injection)
- Difference of Satisfaction of treatment(Baseline to week 24 post-injection)
- Incidence of Treatment-related Adverse Events(week 0 to week 52)