NCT05612958已完成不适用
Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds: Single Center, Prospective, Comparative, Randomized, Double Blinded (Subject, Evaluator), Matched Pairs Design, Non-inferiority, Pivotal Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.
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
- 否
入选标准
- •Age 19 years and older
- •Wrinkle Severity Rating Scale (WSRS) 3 or 4
- •Visually symmetrical bilateral nasolabial folds
- •Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics.
- •Voluntarily decided to participate in the study and signed the informed consent form
- •Willing to follow the protocol
排除标准
- •History of undergoing a permanent or semi-permanent filler treatment on the face
- •Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.
- •Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening
- •History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein
- •Hypersensitivity to Lidocaine or amide local anesthetic
- •Positive for the intradermal response test
- •History of severe or plurality of allergies
- •Having skin inflammation or infection in nasolabial folds
- •History of keloid formation, hyperpigmentation, or hypertrophic scars on the face.
- •History of streptococcal disease
- •Uncontrolled epilepsy
- •Having or being currently suffering from autoimmune diseases
- •History of immunodeficiency or immunosuppressive drugs
- •History of herpetic eruption
- •Having bleeding disorder or blood clotting disorder
- •Having anticoagulant drugs or components within 72 hours from the application of medical advice
- •Received antiplatelet drugs within 2 weeks from the application of medical advice
- •Having high dose vitamin E or nonsteroidal anti-inflammatory drugs (NSAIDs) and high dose vitamin C within one week from the application of medical advice
- •Received drugs that inhibit or decrease liver metabolism
- •Clinically significant abnormalities on electrocardiogram
- •Pregnant or breast-feeding or who planning to conceive
- •Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness
- •Other investigational products or procedures within 3 months from screening
- •Not eligible due to other reasons at the investigator's discretion
结局指标
主要结局
Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.
时间窗: Baseline and Week 24
Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline.
次要结局
- Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48.(Baseline and Weeks 8, 16 and 48.)
- Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48.(Baseline and Weeks 8, 16, 24 and 48.)
- Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48.(Baseline and Weeks 8, 16, 24 and 48.)
- Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48.(Baseline and Weeks 8, 16, 24 and 48.)
- Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48.(Baseline and Weeks 8, 16, 24 and 48.)
- Visual Analog Scale (VAS) after the treatment.(Baseline)
研究者
研究点 (1)
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