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Clinical Study to CMDHA0101 as Compared to PowerFill® 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: NCT03153735
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
CHA MEDITECH Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE May 15, 2017
Last Update Posted Date December 12, 2017
Actual Study Start Date  ICMJE December 2, 2016
Actual Primary Completion Date November 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Subject blind
Primary Purpose: Treatment
Condition  ICMJE
  • Small Penis
  • Penile Enhancement
Intervention  ICMJE
  • Device: CMDHA0101
    Maximum injection dose : 22 ml
  • Device: PowerFill®
    Maximum injection dose : 22 ml
Study Arms  ICMJE
  • Experimental: CMDHA0101
    Maximum injection dose : 22 ml It is a product containing 0.3% lidocaine hydrochloride, a topical anesthetic ingredient, in a crosslinked hyaluronic acid gel
    Intervention: Device: CMDHA0101
  • 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)
    Intervention: Device: PowerFill®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2017)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 7, 2017
Actual Primary Completion Date November 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men over 20 years old and under 65 years of age
  2. In screening, subjects' perception of penile size for dysmenorrhoea syndrome Those who responded with "small", "small", "normal", "large", "very large"
  3. Persons who have agreed to discontinue other procedures or treatments for penile enlargement during the course of the trial
  4. If the person is circumcised or has not undergone circumcision, A person who does not cover the glans
  5. Those who have agreed to abstinence (sexual intercourse, masturbation, etc.) for at least one month after the medical device for clinical trial
  6. Those who can understand and follow instructions
  7. A person who voluntarily participates in the clinical trial and has agreed in writing to the subject consent form

Exclusion Criteria:

  1. A person who has received anticoagulant or antiplatelet agent within 2 weeks before application of medical device for clinical trial or Those who need to be administered until two weeks after application (However, low-dose aspirin (300 mg / day or less) is permitted.
  2. A person who has received a vitamin E preparation, NSAID preparation within 1 week of application of medical device for clinical trial or Those who need to take medicine until 1 week after application
  3. Those who have a history of bleeding in past or present time
  4. Persons who are adversely affected by excessive penis enlargement, which may adversely affect the operation of the medical device
  5. Those who have undergone penis enlargement surgery (fat, alternative dermatologic transplantation) in the past (except for hyaluronic acid or collagen. Two years after transplantation and extension of the penis, such as suprapubic fat preparation and suspension ligament resection In the case of surgery, it is allowed.)
  6. Peyronie's disease of the penis (Peyronie's disease) malformation
  7. Anaphylaxis or severe allergic symptoms.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03153735
Other Study ID Numbers  ICMJE CHA-CMDHA0101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CHA MEDITECH Co., Ltd.
Study Sponsor  ICMJE CHA MEDITECH Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dae Yul Yang, Director Hallym University Kangdong Sacred Heart Hospital
PRS Account CHA MEDITECH Co., Ltd.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP