Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong as Compared to Restylane® Lyft Lidocaine in Temporary Correction of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group
研究概览
简要总结
Background: Nonsurgical injectable treatments have become popular for aesthetic purposes. In recent years, cross-linked hyaluronic acid (HA) fillers containing lidocaine have been used to correct the nasolabial folds.
Aim: The aim of this study was to demonstrate the efficacy and safety of a new HA filler (LASBEAU Strong) (24 mg/mL) compared with a conventional HA filler (Restylane Lyft) for the restoration of nasolabial folds.
Patients/methods: A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler (test group) or the conventional HA filler (control group) on the left or right side of the face. The mean value difference in the Wrinkle Severity Rating Scale (WSRS) scores at week 24 evaluated primary efficacy. The WSRS and the Global Aesthetic Improvement Scale (GAIS) at weeks 8, 16, 24, and 48 evaluated secondary efficacy. Adverse events, laboratory tests, and a check of vital signs at every visit assessed safety.
详细描述
- Introduction
Hyaluronic acid (HA) is a type of glycosaminoglycan that has a repeating structure of sodium glucuronate and N-acetylglucosamine unit sugar and that is known as a component of connective tissue such as joint fluid, oculovitreous fluid, umbilical cord, dermis surface layer, etc. The main function of HA in the extracellular matrix is to stabilize the extracellular structure and form matrix fluid. HA has strong hydrophilicity and functions as a natural supply of moisture to the skin, contributing to its flexibility and swelling. In view of its structural role in tissues, protective effect on cell membranes, and viscoelasticity, HA is ideal as a skin filler. Cross-linking is a process in which HA in a liquid state is transformed into a soft solid or gel by chemically combining each chain of HA. By slowing down HA metabolism in the human body, cross-linked HA can have a long-lasting effect in terms of beauty. Among nonsurgical procedures for wrinkle improvement, soft tissue augmentation using an injectable filler is one of the most frequently performed cosmetic procedures and is widely applied. However, there has been a risk of a serious hypersensitivity reaction due to an immune response caused by various substances. Among them, since HA is a form of polymer with the same structure in all species, cross-linked and nonanimal-stabilized HA derivatives have longer-lasting power and less immune response. The new HA filler is a biomaterial that contains nonanimal-stabilized HA derived from bacterial fermentation and lidocaine, a local anesthetic that reduces pain during the procedure. This product is a cross-linked HA gel, a biomaterial for tissue repair, and was developed to temporarily improve facial wrinkles in the adult face and relieve pain during the procedure. The aim of this trial was to demonstrate that the new HA filler consisting of 24 mg/mL cross-linked HA containing lidocaine was not inferior to the conventional HA filler, which contains the same ingredient for the temporary restoration of nasolabial folds with moderate to severe Wrinkle Severity Rating Scale (WSRS) scores. 2. Materials and methods
2.1 Trial design
This multicenter, randomized, double-blind, split-face clinical trial was conducted from November 2019 to February 2021 at two investigational sites (Asan Medical Center and Nowon Eulji Medical Center) in the Republic of Korea. This trial protocol was approved by the institutional review board of both institutions and followed the guidelines of the 1975 Declaration of Helsinki. All subjects provided written informed consent, including a signed photographic consent form, before participation in the trial.
2.2 Trial population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women over 19 years of age
- •Subjects who wish to temporarily improve their nasolabial folds, those who have a Wrinkle Severity Rating Scale (WSRS) of 3 or 4 points (both do not have to have the same score)
- •Subjects who agree to discontinue all dermatological treatments or treatments (filler, botulinum toxin, laser treatment, chemical exfoliation, cosmetic surgery, etc.) other than the application of clinical trial medical devices during this clinical trial period
- •Can understand and follow instructions, and participate in the pre-clinical period.
- •Subjects who voluntarily decide to participate in this clinical trial and agree in writing to the informed consent form.
排除标准
- •Subjects who administered anti-thrombotic agents (excluding low-dose aspirin (100 mg, up to 300 mg/day) from 2 weeks to 2 weeks after clinical trial application), Vitamin E formulation, and NSAID formulation from 1 week to 1 week after application
- •Subjects with a history of bleeding at the past or present time
- •Subjects who received CaHA (Calcium Hydroxyapatite) or Poly L-Lactide (PLA) filler treatment at the site where the clinical trial device is applied within one year from the screening date
- •Subjects who used local application agents (steroids, retinoids: medicines only) on their face within 4 weeks from the screening date or who are scheduled to use them during the clinical trial (but steroid ointment can be used for a short period of 14 consecutive days for treatment purposes)
- •Subjects who used immunosuppressants, chemotherapy drugs, or systemic corticosteroids within 12 weeks from the screening date
- •Subjectswho received treatment for wrinkle improvement or acne scars within 24 weeks from the screening date
- •Subjects who underwent skin peeling, skin regeneration, or plastic surgery (including botulinum toxin injection) on their face within 24 weeks from the screening date
- •Subjects with the permanent skin-expanding prosthesis such as a cured gel or silicone into the face
- •Subjects with a skin disease or wound infection in the face that affects this clinical trial
- •Those with an autoimmune disease or a history of it or a weakened immune system
- •Those with a history of symptoms of anaphylaxis or severe complex allergies
- •Those with a history of hypertrophic scarring or keloidosis
- •Patients with hypersensitivity to lidocaine or other amide-based local anesthetics
- •A person who has or currently has a severe clinical impairment in the cardiovascular system, digestive system, respiratory system, endocrine system and central nervous system, or has a mental illness that significantly affects this clinical trial
- •Those who participated in other clinical trials within 30 days from the date of screening and received/applied clinical trial medicines/clinical medical devices
- •Among female subjects who are likely to become pregnant, those who do not agree to use contraception* in a medically permitted manner up to 48 weeks after the application of the clinical trial medical device
- •Medically permitted contraception methods: condoms, oral contraception lasting at least three months, using contraceptives for injection or insertion, and installing intrauterine contraceptive devices, etc.
- •Pregnant or lactating woman
- •Anyone who has any clinical significance findings deemed inappropriate for this test by the person in charge or in charge of the test as medically determined above
研究组 & 干预措施
test group
The test device, LASBEAU Strong, was developed for the purpose of temporary improvement of facial nose and lip wrinkles, which is the same indication as the control device, and has a hyaluronic acid structure similar to that of Restylane® Lyft Lidocaine, and was developed using the same crosslinker, 1,4-butanediol diglycidyl ether. The test device, LASBEAU Strong, has a higher content of hyaluronic acid than the control device, Restylane® Lyft Lidocaine, but the clinical efficacy cannot be evaluated as superior because of the high content of hyaluronic acid. This is because, in addition to the content of hyaluronic acid, differences in the manufacturing process can affect the physicochemical properties and decomposition period.
干预措施: LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers (Device)
control group
Restylane® Lyft Lidocaine, a previously licensed product with the same ingredients as the test group, was selected as the control group. Restylane® Lyft Lidocaine is a representative filler formulation that has been recognized for the temporary improvement of facial nose and lip wrinkles, and it was selected as a control group because it is similar to the clinical trial medical device in the test group, and the application site and application method are the same. The control device, Restylane® Lyft Lidocaine, is a product imported and sold by Galderma Korea, which is a bacterial fermentation product and is known as non-animal hyaluronic acid. The purpose of use is to temporarily improve the wrinkles of the nose and lips of the face.
干预措施: LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers (Device)
结局指标
主要结局
Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group
时间窗: at 24 weeks after the application of the clinical trial medical device
Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group evaluated by independent investigators
次要结局
- Differences in GAIS mean values between test and control groups(at weeks 8, 16, 24, and 48 after the filler injections)
- Percentage of subjects with WSRS score improvement of at least 1 point(at 24 and 48 weeks after medical device application)
- The mean value differences in the WSRS scores between the test group and the control group(at weeks 8, 16, 24, and 48 after the filler injections)
研究者
Chong Hyun Won
professor
Asan Medical Center