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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMDHA0101 | Experimental | Maximum injection dose : 22 ml It is a product containing 0.3% lidocaine hydrochloride, a topical anesthetic ingredient, in a crosslinked hyaluronic acid gel |
|
| PowerFill® | Active Comparator | Maximum injection dose : 22 ml A white solid that was lyophilized with mixed spherical PLA (Poly-D, L-lactide) microparticles and CMC (sodium carboxymethylcellulose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMDHA0101 | Device | Maximum injection dose : 22 ml |
| |
| PowerFill® |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in value from the basal value around the penis circumference after using the test device compared to the control device | Measured by value difference | baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in value from the basal value around the penis circumference after using the test device compared to the control device | Measured by value difference | baseline, 4 weeks, 12 weeks, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Yul Yang, Director | Hallym University Kangdong Sacred Heart Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangdong Sacred Heart Hospital, Hallym Univ | Seoul | Gangdong-gu/Gil-dong 445 | 05355 | South Korea |
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| ID | Term |
|---|---|
| C536649 | Penis agenesis |
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Subject blind
| Device |
Maximum injection dose : 22 ml |
|