NCT06428253已完成不适用
A Single Center, Subject & Evaluator-blind, Randomized, Matched Pairs, Active-controlled, Confirmatory Study to Evaluate the Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Improvement rate of IGA-LCL wrinkle severity by external independent evaluators
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of HMM1-022 with Rejuran to improve Crow's feet
详细描述
A single center, subject & evaluator-blind, randomized, matched pairs, active-controlled, confirmatory study to evaluate the efficacy and safety of HMM1-022 in temporary correction of Crow's feet
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)
盲法说明
subject/evaluator blinding
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged 19 years or older
- •Individuals who have voluntarily decided to participate in the clinical trial after receiving and understanding a detailed explanation, and who have provided written consent
- •Individuals who have agreed to discontinue all dermatological treatments, including wrinkle treatments around the eyes, during the clinical trial period
排除标准
- •Individuals with a history of anaphylaxis or severe allergic diseases that may affect the clinical trial
- •Individuals diagnosed with autoimmune diseases, sarcoid granulomatous pathology, or Osler's endocarditis
- •Individuals with hypersensitivity to the investigational medical device, its components (polynucleotide sodium, hyaluronic acid sodium, lidocaine), or other amide-type local anesthetics
- •Individuals with a history of bleeding disorders
- •Individuals with a history of facial nerve paralysis or ptosis
- •Individuals with significant facial asymmetry that may affect the clinical trial
- •Individuals with skin diseases, infections, or abnormalities such as scars in the eye area that could affect the clinical trial
- •Individuals with a history of keloid formation, hyperpigmentation, or hypertrophic scar in the evaluation area
- •Individuals with a history of malignant tumors within 5 years prior to Visit 1 (screening), except those with treated basal cell or squamous cell skin cancer not in the eye area, or treated cervical cancer
- •Individuals with clinically significant disorders or psychiatric conditions affecting the cardiovascular, gastrointestinal, respiratory, endocrine, immune, or central nervous systems, or those with conditions that may significantly impact the clinical trial
- •Individuals who have undergone or are scheduled to undergo treatments affecting the efficacy assessment of crow's feet wrinkles during the following periods:
- •Within 24 months before Visit 1 (screening) using Poly(L-Lactide) or Poly(ε-Caprolactone) for wrinkle treatment
- •Within 18 months before Visit 1 (screening) using Calcium hydroxylapatite (CaHA) for wrinkle treatment
- •Within 12 months before Visit 1 (screening) using hyaluronic acid for wrinkle treatment
- •Within 6 months before Visit 1 (screening) using collagen, botulinum toxin, or other wrinkle treatments
- •Within 6 months before Visit 1 (screening) undergoing invasive laser, deep dermabrasion, or other procedures or surgeries related to wrinkle treatment in the eye area
- •Insertion of permanent skin expansion implants like Softform or silicone in the eye area before screening
- •Starting or receiving a new oral or topical anti-wrinkle medication with wrinkle prevention effects within 3 months before Visit 1 (screening)
- •Individuals who have undergone the following drug therapies that could affect the evaluation of the investigational medical device:
- •Use of NSAIDs, antiplatelet agents, anticoagulants, immunosuppressants within 2 weeks before Visit 1 (screening), or required during the clinical trial period (excluding low-dose aspirin (100 mg, up to 300 mg/day))
- •Use of topical agents (steroids, retinoids: only medications, not cosmetics) in the eye area within 1 month before Visit 1 (screening) or planned use during the clinical trial
- •Individuals who have received a COVID-19 vaccine within 3 weeks before the application of the investigational medical device or are planned to receive it within 4 weeks after application
- •Individuals with ongoing infectious diseases, including COVID-19, or suspected COVID-19 infection within 2 weeks before screening
- •Individuals who have been administered or undergone other investigational drugs or devices within 1 month before Visit 1 (screening), or within 6 months for studies related to crow's feet wrinkles
- •Individuals with positive results for viral tests (HBs Ag, HCV Ab, HIV Ab) performed at Visit 1 (screening) or within 1 month before screening
- •Individuals with a history of alcohol or drug addiction
- •Pregnant or breastfeeding women
- •Individuals planning to become pregnant during the clinical trial or those who, along with their partners (or spouses), do not agree to use medically acceptable contraception methods (examples include: hormonal contraceptives, proven failure rates intrauterine devices (IUDs), double barrier methods, sterilization)
- •Individuals deemed unsuitable for participation in the clinical trial based on the investigator's judgment
研究组 & 干预措施
HMM1-022
Experimental
Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.
干预措施: HMM1-022 (Device)
REJURAN®
Active Comparator
Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals.
干预措施: HMM1-022 (Device)
结局指标
主要结局
Improvement rate of IGA-LCL wrinkle severity by external independent evaluators
时间窗: 18 weeks
Improvement rate of 1 point or more on the crow's feet at rest IGA-LCL severity scale by external independent evaluators at 18 weeks after initial injection
次要结局
- Improvement rate of IGA-LCL wrinkle severity by external independent evaluators(8, 10 weeks)
- Change in GAIS scores assessed by an independent evaluator(8, 10, 18 weeks)
- Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator(8, 10, 18 weeks)
- Change in GAIS scores assessed by the subject(8, 10, 18 weeks)
- Improvement rate of GAIS for both crow's feet as assessed by the subject(8, 10, 18 weeks)
研究者
研究点 (1)
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