Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 3:34 AM
Study NCT ID:
NCT01775293
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
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
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 06-2012-208 | OTHER | Seoul National University Bundang Hospital | View |