Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh

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: NCT01775293
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
D.med
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:

The aim of this study is to evaluate the efficacy and safety of the investigational device, RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.

Study hypothesis

  • level of significance: alpha=0.05( two-side)
  • power of test: (power= 1-beta),power=0.08
  • H0: P equals P0
  • H1: P unequals P0
  • The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)

Condition or disease Intervention/treatment Phase
Nasolabial Fold Device: Non-absorbable polypropylene mesh Not Applicable

Detailed Description:

1. Benefits

  • enhancing self-satisfaction and quality of life by improving skin elasticity and correcting folds in the nasolabial fold area 2. Risks
  • erythema, swelling, pain and redness in the facial area generally resolve in 1 week 3.Duration of study
  • entire duration: approximate 36weeks
  • Follow-up period: 7 weeks
  • Enrollment period: 12 weeks 4. study design
  • 2 step operation process

    • First step- insert polypropylene mesh under the skin
    • Second step- pull the polypropylene mesh 3 weeks later

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Center, Non-comparative Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety After Rhytidectomy Using Non-absorbable Mesh(RPM)
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: Non-absorbable polypropylene mesh

2 step procedures

  • first step is insertion of Non-absorbable polypropylene mesh under the facial skin
  • second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step
Device: Non-absorbable polypropylene mesh

2 step procedures

  • first step is insertion of Non-absorbable polypropylene mesh under the facial skin
  • second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step




Primary Outcome Measures :
  1. The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration [ Time Frame: change in the WSRS from baseline at7 week ]

    The efficacy is assessed by the severity of the fold determined by the WSRS assessed by the investigator with photos WSRS(Wrinkle Severity Rating Scale)is be evaluated from 1 to 5 according to the severity of wrinkles

    (1= no visible fold, 5= extremely deep and long fold)



Secondary Outcome Measures :
  1. The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration [ Time Frame: Changes Satisfaction from baseline at 7week ]
    The changes in the satisfaction(VAS-visual analog scale) of the pre and post rhytidectomy from baseline at 7week after administration VAS(visual analog scale)is to be evaluated from 0 to 100 by the participant ( 0= no wrinkle, 100= severe wrinkle)



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.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who had soft tissue sagging around nasolabial fold
  • Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS)
  • Subjects who voluntary decided to participate in the study and signed the informed consent

Exclusion Criteria:

  • Subjects who have a skin disease on the face
  • Subjects who have severe facial skin disease
  • Subjects who are constantly taking anti-coagulants including aspirin
  • Subjects who have too thin or thick skin
  • Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease
  • Subjects who had an allergy to non-absorbable material.
  • Subjects who are taking immune suppressants
  • General weakness status
  • Pregnant or lactating women
  • Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease,
  • Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face
  • Subjects who participated in other clinical trial within 30 days from screening

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): NCT01775293


Locations
Layout table for location information
Korea, Republic of
Korea University Anam Hospital
Seoul, Seongbukgu/Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Seoul National University Hospital
D.med
Investigators
Layout table for investigator information
Principal Investigator: Chanyeong Heo, Master Seoul National University Hospital

Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01775293     History of Changes
Other Study ID Numbers: E-1209-170-002
06-2012-208 ( Other Identifier: Seoul National University Bundang Hospital )
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Seoul National University Hospital:
Non-absorbable polypropylene mesh
WSRS
Rhytidectomy