NCT01775293

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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)

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

Conditions

• Nasolabial Fold

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2013-01-24
• Last updated: 2014-01-07

Locations

1 site across 1 country: South Korea