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

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.

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Key information

Conditions

Penile Girth Enhancement Penile Enhancement

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Korea university guro hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Potenfill

Device

Maximum: 22ml

Other names: hyaluronic acid filler

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 15, 2019
Registry last updated: Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed