Nasolabial Fold
Conditions
Keywords
Non-absorbable polypropylene mesh, WSRS, Rhytidectomy
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
Interventions
DEVICENon-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
D.med
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who had soft tissue sagging around nasolabial fold * Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS) * Subjects who voluntary decided to participate in the study and signed the informed consent
Exclusion criteria
* Subjects who have a skin disease on the face * Subjects who have severe facial skin disease * Subjects who are constantly taking anti-coagulants including aspirin * Subjects who have too thin or thick skin * Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease * Subjects who had an allergy to non-absorbable material. * Subjects who are taking immune suppressants * General weakness status * Pregnant or lactating women * Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease, * Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face * Subjects who participated in other clinical trial within 30 days from screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration | change in the WSRS from baseline at7 week | The efficacy is assessed by the severity of the fold determined by the WSRS assessed by the investigator with photos WSRS(Wrinkle Severity Rating Scale)is be evaluated from 1 to 5 according to the severity of wrinkles (1= no visible fold, 5= extremely deep and long fold) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration | Changes Satisfaction from baseline at 7week | The changes in the satisfaction(VAS-visual analog scale) of the pre and post rhytidectomy from baseline at 7week after administration VAS(visual analog scale)is to be evaluated from 0 to 100 by the participant ( 0= no wrinkle, 100= severe wrinkle) |
Countries
South Korea
Outcome results
None listed