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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.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Small Penis Penile Enhancement Device: CMDHA0101 Device: PowerFill® Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Subject blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2, 2016
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 7, 2017
Arms and Interventions
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Arm Intervention/treatment
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
 Device: CMDHA0101
Maximum injection dose : 22 ml
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)
 Device: PowerFill®
Maximum injection dose : 22 ml


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
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): NCT03153735


Locations
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Korea, Republic of
Gangdong Sacred Heart Hospital, Hallym Univ
Seoul City, Gangdong-gu/Gil-dong 445, Korea, Republic of, 05355
Sponsors and Collaborators
CHA MEDITECH Co., Ltd.
Investigators
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Study Director: Dae Yul Yang, Director Hallym University Kangdong Sacred Heart Hospital
More Information
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Responsible Party: CHA MEDITECH Co., Ltd.
ClinicalTrials.gov Identifier: NCT03153735    
Other Study ID Numbers: CHA-CMDHA0101
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
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
Keywords provided by CHA MEDITECH Co., Ltd.:
Hyaluronic acid
Small Penis
Penile Enhancement