KCT0008324已完成Unknown
Comparative clinical study of efficacy and safety between GESELLELIGNE and Juvederm Voluma for restoration of mid-face volume deficit; A multi-center, randomized, single-blinded, investigator initiated trial
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Men and women between the ages of 30 and 65
- •2) Those who need correction of mid-face volume deficit scale (MFVDS) grade 2 or higher facial volume
- •3) Those whose face volume is bilaterally symmetrical
- •4) Those who agreed not to undergo other facial correction procedures during the clinical trial period
- •5) A person who is willing to participate in a clinical trial, comply with treatment and procedures, and visit a hospital for all observation evaluations
- •6) A person who voluntarily signed a written consent after hearing the explanation about the purpose and method of this clinical trial
排除标准
- •1) Those who have taken anticoagulants within 2 weeks before participating in the clinical trial (however, low-dose (300 mg/day or less) aspirin administration is allowed.)
- •2) Those who have applied calcium hydroxyapatite (CaHA) to the target area of this study within 1 year before participating in the clinical trial
- •3) Those who administer immunosuppressants
- •4) Those who have undergone permanent filler treatment or fat grafting in the area subject to this study
- •5) Those who have undergone wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, middle skin peel, dermal photorejuvenation, etc.) within 6 months prior to participation in the clinical trial
- •6) Those with a history of hypersensitivity to lidocaine or hyaluronic acid
- •7) Those with a history of keloid formation or hypertrophic scars on the face
- •8) Those with a history of streptococcal infectious disease on the face
- •9) Subjects with wounds, scars, skin disorders or infections around the area subject to this study that may affect efficacy evaluation
- •10) If those are pregnant or lactating, or if those are a woman of childbearing age, those do not agree to maintain contraception during the clinical trial period (*Medically accepted contraception methods: use condoms, oral contraception continued for at least 3 months, or injection or insertion contraceptives) If those do, if those have an intrauterine contraceptive device installed, etc.)
- •11) Those who participated in clinical trials of other drugs or medical devices within 4 weeks of screening and received drugs or applied medical devices
- •12) Those who are judged inappropriate to participate in the test by other testers
研究者
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