A Prospective, Split-face, Randomized, Comparative Trial on the Efficacy of Two Hyaluronic Acid Products (Restylane + Lidocaine and Restylane Lyft) for the Treatment of Nasolabial Folds
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Skin lifting capacity of two Restylane products, as assessed by ultrasound
研究概览
简要总结
This study is designed to assess and compare the efficacy of two hyaluronic acid (HA) fillers on moderate, severe and extreme nasolabial folds (NLF).
详细描述
Background
One of the most significant signs of aging is the appearance of deep lines that run from each side of the nose to the corners of the mouth [i.e., nasolabial folds (NLFs)]. These folds are defined by facial structures that support the buccal fat pad and separate the cheeks from the upper lip. The NLFs form due to volume shifts in the face, caused by a combination of fat descent and bone absorption, which results in sagging skin and hollowing.
Soft tissue augmentation can effectively restore the youthful, harmonious contours of the face. The most popular non-invasive treatment options for volume loss in the face include the use of hyaluronic acid (HA) fillers. Injections of HA for skin rejuvenation are one of the most common aesthetic treatments performed worldwide. Due to their effectiveness, safety, low immunogenicity (HA is a normal component of human skin) and reversibility with hyaluronidase, HA fillers are understandably a popular option for facial volume restoration.
Through recent advances in manufacturing technology, various types of HA fillers have been approved for the correction of facial wrinkles and folds, such as NLFs. Two such fillers, i) Restylane + Lidocaine and ii) Restylane Lyft, are well tolerated and provide significant improvement in this indication. These products contain the same amount of HA (i.e., 20mg/mL) and are manufactured using the same technology [i.e., non-animal stabilized hyaluronic acid (NASHATM)], but differ primarily in their particle size.
Small particle size HA (Restylane + Lidocaine): was the first non-animal stabilized HA-containing filler approved for use in the United States. Because of its particle size (i.e., 330-430 μM), Restylane + Lidocaine is referred to as small gel-particle HA (SGP-HA). NASHA small gel contains approximately 100,000 gel particles per mL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At the time of consent, women between the ages of 30 and 75 years old;
- •Indication for treatment of bilateral NLFs and wrinkles;
- •Willingness to comply with study requirements;
- •Provide written consent;
- •Accepted the obligation not to receive any other facial procedures through the follow-up;
- •Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
- •No previous facial fillers for a period of 12 months prior to this study;
- •No previous facial fillers in the complete region of the NLF for 18 months prior to this study
排除标准
- •Current pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- •Hypersensitivity to hyaluronic acid or local anesthetics;
- •Patients meeting any official Restylane contra-indications;
- •Patients presenting with porphyria;
- •Inability to comply with follow-up and abstain from facial injections during the study period;
- •Heavy smokers, classified as smoking more than 12 cigarettes per day;
- •History of severe or multiple allergies manifested by anaphylaxis;
- •Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
- •Previous maxillofacial surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
- •History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
- •Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area;
- •Cancer or precancer in the treatment area, e.g. actinic keratosis;
- •History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
- •Patients using immunosuppressants;
- •Patients with a tendency to form hypertrophic scars or any other healing disorders;
- •Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
- •Patients administered dental block or topical administration of lidocaine;
- •Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
结局指标
主要结局
Skin lifting capacity of two Restylane products, as assessed by ultrasound
时间窗: Baseline
The lifting capacity of two Restylane products (i.e., Restylane + Lidocaine and Restylane Lyft) will be assessed post-injection, using a skin ultrasound.
次要结局
- Skin lifting capacity of two Restylane products, as assessed by ultrasouns(Week 2)