A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The difference in value from the basal value around the penis circumference after using the test device compared to the control device
研究概览
简要总结
The investigators aimed to confirm the efficacy and safety of transdermal penis enlargement for 24 weeks after CMDHA0101 injection in subjects who wanted penile enlargement in male patients with small-penis syndrome *.
*Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it isn't.
详细描述
This study was designed as a 24-week, randomized, blinded, active control trial.
If a subject signing a clinical trial agreement and satisfying the selection / exclusion criteria is enrolled in this clinical trial, he / she will receive the medical device for clinical testing at the baseline time, return to his / her home after the training . At 4 weeks, 12 weeks, and 24 weeks after the application of the medical device for clinical testing at baseline, the safety, penile girth, length, and satisfaction of the subject were evaluated. 24 weeks after application, the clinical trial sponsor (or trustee) retrieves the data necessary for the analysis of results, such as case records, for the purpose of validity and safety evaluation
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
- Single (Participant)
盲法说明
Subject blind
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men over 20 years old and under 65 years of age
- •In screening, subjects' perception of penile size for dysmenorrhoea syndrome Those who responded with "small", "small", "normal", "large", "very large"
- •Persons who have agreed to discontinue other procedures or treatments for penile enlargement during the course of the trial
- •If the person is circumcised or has not undergone circumcision, A person who does not cover the glans
- •Those who have agreed to abstinence (sexual intercourse, masturbation, etc.) for at least one month after the medical device for clinical trial
- •Those who can understand and follow instructions
- •A person who voluntarily participates in the clinical trial and has agreed in writing to the subject consent form
排除标准
- •A person who has received anticoagulant or antiplatelet agent within 2 weeks before application of medical device for clinical trial or Those who need to be administered until two weeks after application (However, low-dose aspirin (300 mg / day or less) is permitted.
- •A person who has received a vitamin E preparation, NSAID preparation within 1 week of application of medical device for clinical trial or Those who need to take medicine until 1 week after application
- •Those who have a history of bleeding in past or present time
- •Persons who are adversely affected by excessive penis enlargement, which may adversely affect the operation of the medical device
- •Those who have undergone penis enlargement surgery (fat, alternative dermatologic transplantation) in the past (except for hyaluronic acid or collagen. Two years after transplantation and extension of the penis, such as suprapubic fat preparation and suspension ligament resection In the case of surgery, it is allowed.)
- •Peyronie's disease of the penis (Peyronie's disease) malformation
- •Anaphylaxis or severe allergic symptoms.
研究组 & 干预措施
CMDHA0101
Maximum injection dose : 22 ml It is a product containing 0.3% lidocaine hydrochloride, a topical anesthetic ingredient, in a crosslinked hyaluronic acid gel
干预措施: CMDHA0101 (Device)
PowerFill®
Maximum injection dose : 22 ml A white solid that was lyophilized with mixed spherical PLA (Poly-D, L-lactide) microparticles and CMC (sodium carboxymethylcellulose)
干预措施: PowerFill® (Device)
结局指标
主要结局
The difference in value from the basal value around the penis circumference after using the test device compared to the control device
时间窗: baseline, 24 weeks
Measured by value difference
次要结局
- The difference in value from the basal value around the penis circumference after using the test device compared to the control device(baseline, 4 weeks, 12 weeks, 24 weeks)