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

NCT01775293 | Completed

• 2 other identifiers: E-1209-170-00206-2012-208
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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)

Conditions

Nasolabial Fold

Keywords

Non-absorbable polypropylene mesh; WSRS; Rhytidectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration

  Changes Satisfaction from baseline at 7week

Study Arms (1)

Non-absorbable polypropylene mesh

EXPERIMENTAL

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

Interventions

Non-absorbable polypropylene mesh DEVICE

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

Non-absorbable polypropylene mesh

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• D.med: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbukgu/Seoul, 136-705, South Korea

Location

Study Officials

• Chanyeong Heo, Master

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

KR (1)