Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01775293
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)
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
Study:
NCT01775293
Study Brief:
Protocol Section:
NCT01775293