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

Seoul National University Hospital28 enrolled

Overview

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)

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasolabial Fold

Interventions

Non-absorbable polypropylene meshDEVICE

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

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Korea University Anam Hospital

Seoul, Seongbukgu/Seoul, South Korea

Outcomes

Primary Outcomes

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)

Time frame: change in the WSRS from baseline at7 week

Secondary Outcomes

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)

Time frame: Changes Satisfaction from baseline at 7week

Data from ClinicalTrials.gov

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