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Clinical Trials/NCT03840070
NCT03840070CompletedNot Applicable

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

Medy-Tox1 site in 1 country20 target enrollmentStarted: December 17, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Subject satisfaction on the penile appearance at 12 months after application of Potenfill
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male subjects aged above 19 and below
  • •(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.

Arms & Interventions

Potenfill

Experimental

Intervention: Potenfill (Device)

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Medy-Tox
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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