Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement
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|ClinicalTrials.gov Identifier: NCT03153735|
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : December 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Small Penis Penile Enhancement||Device: CMDHA0101 Device: PowerFill®||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Subject blind|
|Official Title:||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|
|Actual Study Start Date :||December 2, 2016|
|Actual Primary Completion Date :||November 7, 2017|
|Actual Study Completion Date :||November 7, 2017|
Maximum injection dose : 22 ml It is a product containing 0.3% lidocaine hydrochloride, a topical anesthetic ingredient, in a crosslinked hyaluronic acid gel
Maximum injection dose : 22 ml
Active Comparator: 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)
Maximum injection dose : 22 ml
- The difference in value from the basal value around the penis circumference after using the test device compared to the control device [ Time Frame: baseline, 24 weeks ]Measured by value difference
- The difference in value from the basal value around the penis circumference after using the test device compared to the control device [ Time Frame: baseline, 4 weeks, 12 weeks, 24 weeks ]Measured by value difference
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153735
|Korea, Republic of|
|Gangdong Sacred Heart Hospital, Hallym Univ|
|Seoul City, Gangdong-gu/Gil-dong 445, Korea, Republic of, 05355|
|Study Director:||Dae Yul Yang, Director||Hallym University Kangdong Sacred Heart Hospital|