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