Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 发起方
- Bioplus
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device
研究概览
简要总结
Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.
Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- & evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design
Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)
Population: Number of subject 100
* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 19 years of age or older
- •Seeking temporary improvement of bilateral nasolabial folds, with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (does not have to be the same on both sides)
- •Agrees to discontinue all dermatologic procedures or treatments (fillers, botulinum toxin, laser treatments, chemical peels, surgery for cosmetic purposes, etc.) other than investigational device application, including facial wrinkle improvement
- •Able to understand and follow instructions and able to participate in all periods of the investigation
- •Made a voluntary decision to participate in this investigation and gave written informed consent
排除标准
- •Took antithrombotic agents (except low-dose aspirin (100 mg, maximum 300 mg/day)) from 2 weeks before to 2 weeks after application of the investigational device; took vitamin E formulations or NSAID formulations from 1 week before to 1 week after application
- •History of bleeding disorder in the past or at the time of screening
- •CaHA (Calcium Hydroxyapatite) or PLLA (Poly L-Lactide) filler treatment at the site of application of the investigational medical device within 1 year before the screening date
- •Has used or intends to use topical agents (steroids, retinoids: medicines only, excluding cosmetics) on the facial area within 4 weeks before the screening date or during the clinical trial period (however steroid ointments for therapeutic purposes may be used for a short period of time within 14 consecutive days).
- •Used immunosuppressants, chemotherapeutic agents, or systemic corticosteroids within 12 weeks before the screening date.
- •Received any anti-wrinkle or acne scar treatment within 24 weeks before the screening date.
- •Received dermabrasion, skin resurfacing, or cosmetic surgery (including botulinum toxin injections) to the facial area within 24 weeks before the screening date
- •Permanent skin augmentation implants such as hardened gel (Softform) or silicone in the facial area
- •Skin diseases or wound infections in the facial area that would affect this investigation
- •History of autoimmune disease
- •Hypersensitivity to sodium hyaluronate
- •History of streptococcal disease
- •History of anaphylaxis or severe multiple allergies
- •History of hypertrophic scars, hyperpigmentation or keloids
- •Hypersensitivity to lidocaine or other amide local anesthetics
- •Coagulation disorders
- •Clinically significant disorders of the cardiovascular, digestive, respiratory, endocrine, or central nervous systems or a psychiatric illness that significantly affects this investigation
- •Participated in another clinical investigation within 30 days before the screening date and received/applied an investigational drug/investigational medical device
- •Female subjects of childbearing potential who do not agree to use a medically acceptable method of contraception* until 48 weeks after application of the investigational medical device in this investigation. (*Medically accepted methods of contraception include: condoms, oral contraception continued for at least 3 months, use of injectable or insertable contraceptives, intrauterine contraceptive devices, etc.)
- •Pregnant or lactating women
- •Used steroid medication for therapeutic purposes (immune diseases, musculoskeletal diseases, etc.) within 4 weeks prior to enrollment in the investigation, or plans to use steroid medication during the investigation period
- •Used or intends to use functional cosmetics for wrinkle improvement within 4 weeks before participation in the investigation or during the investigation period
- •In addition to the above, those who have clinical significant findings that are considered inappropriate for this investigation by the principal investigator or personnel in charge, based on medical judgment.
研究组 & 干预措施
Investigational Medical Device
Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine)
干预措施: Investigational medical device (SkinPlus-HYAL Implant Lidocaine) (Device)
Active Comparator Medical Device
Application of the control device (RESTYLANE Lidocaine)
干预措施: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) (Device)
结局指标
主要结局
Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device
时间窗: 24 weeks
Descriptive statistics (number of observed subjects, mean, standard deviation, median, minimum, and maximum) for WSRS scores assessed by independent evaluators at 24 weeks after clinical trial device application by treatment group are presented. If the upper limit of the 97.5% one-sided confidence interval by t-distribution is less than 0.29 for the difference between treatment groups (test-control), it is judged that the non-inferiority of the test group has been demonstrated compared to the control group. WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
次要结局
- Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application(8, 16, 24, 48 weeks)
- Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application(8, 16, 24, 48 weeks)
- Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application.(48 weeks)