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

Seoul National University

Status: Completed

Conditions: Nasolabial Fold

Treatments: Device: Non-absorbable polypropylene mesh

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01775293

E-1209-170-002

06-2012-208 (Other Identifier)

Details and patient eligibility

About

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)

Full 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

Enrollment: 28 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Non-absorbable polypropylene mesh

Experimental group

Description:

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

Treatment:

Device: Non-absorbable polypropylene mesh