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

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)

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)

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold
• Intervention / Treatment: Device: Non-absorbable polypropylene mesh

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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongbukgu/Seoul
    • Seoul, Seongbukgu/Seoul, Korea, Republic of, 136-705
      • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration	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)	change in the WSRS from baseline at7 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration	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)	Changes Satisfaction from baseline at 7week

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: D.med
• Investigators: Principal Investigator: Chanyeong Heo, Master, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 22, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Estimate): January 7, 2014
• Last Update Submitted That Met QC Criteria: January 6, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Rhytidectomy; Non-absorbable polypropylene mesh; WSRS
• Other Study ID Numbers: E-1209-170-002; 06-2012-208 (Other Identifier: Seoul National University Bundang Hospital)