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

Nasolabial Fold Clinical Trial

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)

Status Completed

Clinical Trial 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)

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Fold

• NCT number: NCT01775293
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: January 2014