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The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03840070
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Study Description
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Brief Summary:

This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis.

This study will determine the long-term efficacy and safety of Potenfill.


Condition or disease Intervention/treatment Phase
Penile Girth Enhancement Penile Enhancement Device: Potenfill Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : October 17, 2019
Actual Study Completion Date : December 30, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Potenfill Device: Potenfill
Maximum: 22ml
Other Name: hyaluronic acid filler


Outcome Measures
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Primary Outcome Measures :
  1. Subject satisfaction on the penile appearance at 12 months after application of Potenfill [ Time Frame: 12 month ]
    Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects aged above 19 and below 65. (20≤male≥65)
  • Subjects will sign an informed consent form

Exclusion Criteria:

  • Prior treatment for penile enhancement (e.g. fat, dermal graft).
  • Allergic to hyalluronic acid.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03840070


Locations
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Korea, Republic of
Korea university guro hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Medy-Tox
More Information
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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03840070    
Other Study ID Numbers: MT05-KR18PGE1005
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Viscosupplements
Protective Agents