KCT0002639已完成未知
A Multicenter, Randomized, Evaluator and Subject Blind, Split-face, Comparative Medical Device Pivotal Clinical Study of Dermalax Implant to Evaluate the Efficacy and Safety compared to Juvederm Voluma with Lidocaine for Temporary Restoring the Mid-face Volume
Across0 个研究点目标入组 106 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 35(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Man and woman aged 35 to 65
- •2) The volume of the frontal middle part or the cadaver area of ??both sides, the frontal part of the ball, and the lower part of the clown was 3 points (moderate) or more on both sides symmetrically as a result of independent field evaluator's MFVDS evaluation
- •3) Those who agreed not to receive filler, botulinum toxin, laser treatment, chemical peeling, or cosmetic surgery in the middle of the face during the clinical trial.
- •4) After thoroughly listening to the detailed explanation of the clinical trial, it is decided to participate voluntarily and agree with the written consent of the subject.
排除标准
- •1) Those who have taken the drug within 10 days from the date of application of the clinical test medical device or who are scheduled to take the following drug within 3 days after the application (but it is possible to apply the medical device for clinical test after 10 days of in vitro release);
- •(Up to 300 mg / day dose is acceptable for low dose aspirin (less than 100 mg / Tablet)) and blood clotting time is delayed (eg, oral anticoagulants, anticoagulants, antiplatelet agents, Ingredients (Vitamin E, Garlic, Ginkgo biloba, etc.)
- •2) Before the screening, cosmetic surgery (except for upper eyelid surgery and postoperative 24-month nose surgery or lower eyelid correction) for facial cosmetic purposes or tissue grafting or tissue enlargement of silicone, fat, permanent or semi-permanent filler Or who is scheduled to be administered during the clinical trial
- •3) Those who have undergone facial procedures under the edge of orbit within 6 months from the screening date
- •4) Hyaluronic acid filler in the facial area within 12 months from the screening date, or donor collagen filler within 24 months or scheduled to be performed during the clinical trial5) Within 6 months from the screening date, a person who has undergone neuromodulator injections or mesotherapy, skin regeneration (laser, wave length, high frequency, mechanical or chemical peeling)
- •6) Those who received calcium hydroxyapatite (CaHA) treatment within 12 months from the screening date
- •7) Within 3 months from the screening date Oral or topical medicines, medicines or cosmetics (alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) Who will take / use
- •8) Those who have a thin skin on the central part of the face and tend to accumulate body fluid on the lower eyelid or orbital floor pad
- •9) Patients with acute abdominal fat associated with immune-mediated diseases such as congenital defects, trauma or systemic lipodystrophy,
- •10) Those who had a scarring disease (chickenpox, malignant acne, etc.) within 12 months, or who had scars or marks on the medical device
- •11) Those with skin diseases (skin infections, eczema, psoriasis, injections, herpes, etc.) or wound infections affecting the clinical trial
- •12) Persons with impaired or suspected immunity, patients with autoimmune disease
- •13) Anaphylaxis or severe allergic (allergy) Those with a history of symptoms
- •14) Those with a history of hypertrophic scars or keloids
- •15) Persons who are sensitive to lidocaine or amide-based local anesthetics
- •16) Those who have clinically severe impairment in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or have a mental illness that has a significant effect on the trial
- •17) Malignant tumor patients
- •18) Those who participated in other clinical trials within 30 days from the screening date
- •19) Contraceptive use of medically acceptable methods (condoms, contraceptive methods continued for at least 3 months, intrauterine contraceptive devices, etc., when using contraceptive or injectable contraceptives) Do not agree with
- •20) Pregnant or lactating women
- •21) Those who have clinical findings that are deemed inappropriate for this clinical trial,
研究者
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