KCT0007664招募中未知
A Single-Center, Single-arm, Open-label, Exploratory Study to Evaluate the Efficacy and Safety of Intradermal Injection of Hyaluronic Acid Filler
Hugel0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- 30(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •(1) Adult men and women between the ages of 30 and 60
- •(2) Those who show a decrease in skin elasticity when the cheek fold wrinkles are 2 or higher on the Lemperle wrinkle scale in the consultation with a dermatologist
- •(3) A person who can follow the procedures of clinical trials well and adhere to the visit schedule
- •(4) Those who agree to suspend all dermatological treatments or treatments, including facial wrinkle correction, during the clinical trial period
- •(5) Those who voluntarily agreed to participate in this clinical trial and provided written consent
排除标准
- •(1) Those who have received filler or botulinum toxin treatment for 12 months before registration
- •(2) Those who have undergone facial wrinkle correction surgery (e.g., facelift, soft tissue augmentation, chemical dermabrasion, dermal photorejuvenation, laser treatment, etc.) within 6 months before participating in the clinical trial or are expected to receive it during the study period
- •(3) Those who have inflammatory and/or infectious diseases in the facial region that can affect clinical trials
- •(4) A person who has had a skin graft on the face
- •(5) Those who have had keloids or hyperproliferative wounds on the face
- •(6) Those who have had bleeding disorders in the past or present
- •(7) Aspirin administration is permitted for bleeding patients, those receiving anticoagulant treatment, or those who have taken antiplatelet or anticoagulant drugs 2 weeks prior (however, a low dose of 300mg/day or less).
- •(8) Those who have undergone autoimmune disease or immunotherapy
- •(9) Persons with a history of anaphylaxis or severe complex allergic symptoms
- •(10) Those who are allergic to or sensitive to clinical investigational drugs or their ingredients
- •(11) Pregnant, lactating, or pregnant women who do not consent to contraception by a medically acceptable method up to 8 weeks after administration of the drug
- •(12) Persons suffering from severe heart disease or respiratory disease
- •(13) Those who participated in other clinical trials within 4 weeks before participating in clinical trials and received clinical trial drugs or clinical trial equipment
- •(14) Others who are judged inappropriate for participation in this clinical trial by the person in charge of the clinical trial
研究者
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