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

NCT01775293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-01-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • D.med

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Chanyeong Heo, Master · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01775293 on ClinicalTrials.gov