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

This study has been completed.
Sponsor:
Collaborator:
D.med
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01775293
First received: January 22, 2013
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention
Nasolabial Fold
Device: Non-absorbable polypropylene mesh

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 28
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775293

Locations
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
Principal Investigator: Chanyeong Heo, Master Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01775293     History of Changes
Other Study ID Numbers: E-1209-170-002, 06-2012-208
Study First Received: January 22, 2013
Last Updated: January 6, 2014
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

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

ClinicalTrials.gov processed this record on April 17, 2014