Penile Enhancement
Conditions
Brief summary
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.
Interventions
DEVICEPotenfill
Maximum: 22ml
DEVICEPowerfill
Maximum: 22ml
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male subjects aged above 19 and below 65. (20≤male≥65) 2. be rating himself, when screening, as Small or Very Small on Self-Questioned Questionnaire ( SQQ) including the question: How do you rate your penile size? // Very small, Small, Normal, Big, Very Big? 3. Subjects will sign an informed consent form
Exclusion criteria
1. Prior treatment for penile enhancement (e.g. fat, dermal graft). 2. Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention 3. Allergic to hyalluronic acid. 4. Inflammatory or/and infectious disease on penis that can affect on this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Penile Circumference difference at 24 weeks from baseline | 24 weeks | Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement |
Countries
South Korea
Outcome results
None listed