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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775293
Other study ID # E-1209-170-002
Secondary ID 06-2012-208
Status Completed
Phase N/A
First received January 22, 2013
Last updated January 6, 2014
Start date January 2013
Est. completion date January 2014

Study information

Verified date January 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry for Health and Welfare
Study type Interventional

Clinical Trial 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)


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


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 65 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Korea University Anam Hospital Seoul Seongbukgu/Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital D.med

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration 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)
change in the WSRS from baseline at7 week No
Secondary The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration 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) Changes Satisfaction from baseline at 7week No
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