KCT0001098已完成未知
A Multicenter, Randomization, Open Clinical study to Evaluate the Efficacy and Safety of MINTLIFT® group Vs. No Treatment group for Nasolabial Fold
Hans Biomed Corporation0 个研究点目标入组 62 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 62
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
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) at the time of the screening and at the baseline time point
- •Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this clinical test
排除标准
- •Patients who have a scar or hypertrophic scar or a history of keloid conditions that may affect the determination of effect
- •Patients allergic to local anesthetics or sleep anesthetics
- •Patients whose ALT/AST ratio is 2.5 times or more greater than the normal upper limit
- •Individuals who have been administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening, or who require an anticoagulant during the period of the clinical test
- •Individuals who have been administered systemic corticosteroids or anabolic steroids within two weeks of the date of the screening or who require their administration during the period of the clinical test (note, however, that the administration of inhaled corticosteroids in a standardized dosage is permissible)
- •Individuals who have been administered Vitamin E or non-steroidal anti-inflammatory drugs within 1 week of the date of the screening
- •Individuals who have used Topical liniments in the facial area (steroids, retinoids: only medical drugs are included in this criteria, with the exclusion of cosmetic products) within 4 weeks of the date of the screening or who plan on continuing usage during the period of the clinical test
- •Individuals who have received wrinkle reduction treatment using Calcium-Hydroxyapatite within 1 year of the date of the screening
- •Individuals who have received wrinkle reduction treatment using collagen or Hyaluronic Acid filler within 6 months of the date of the screening, or who have received acne treatment, skin regeneration procedures, or cosmetic surgical procedures (including Botox injections) in the facial area
- •Individuals who have a permanent skin expanding implant such as Softform or silicon inserted in the facial area
- •Individuals who have scars in the facial area requiring treatment that has not healed for a period of 1 year or longer, or who have a scar or trace in the area on which the clinical test device will applied.
- •Individuals who have a chronic or recurrent infection or a history of inflammatory disease that may affect this clinical test
- •Individuals with liver function disorders or coagulation disorders
- •Individuals who have experienced severe allergies such as symptoms of anaphylaxis
- •Individuals with decreased immunity
- •Individuals who exhibit severe impairments in their cardiovascular, digestive, respiratory, endocrine, or central nervous system or who have had or currently have a mental illness that will have a significant effect on this clinical test
- •Individuals who have participate in another clinical test within 30 days of the date of the screening
- •Female subjects with the possibility of becoming pregnant during the period of the clinical test who have not consented to a *medically acceptable method of contraception
- •* Medically acceptable methods of contraception: condoms, oral contraceptives administered for at least three month or longer, the usage of injected or inserted contraceptives, the installation of a contraceptive device within the uterus, etc.
- •Pregnant women or lactating mothers
- •In addition to the above, any other individual with clinically significant findings judged to render the individual unsuitable for the test as determined by the test supervisor or other personnel in charge of the test
研究者
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