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

Study Overview
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Brief Summary
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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)

Detailed Description
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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

Official Title
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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)

Conditions
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Nasolabial Fold

Intervention / Treatment
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* Device: Non-absorbable polypropylene mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-absorbable polypropylene mesh<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-absorbable polypropylene mesh, WSRS, Rhytidectomy