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

NCT ID: NCT01775293

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-01-31

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

Conditions

Nasolabial Fold

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Non-absorbable polypropylene mesh

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

D.med

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chanyeong Heo, Master

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Korea University Anam Hospital

Seoul, Seongbukgu/Seoul, South Korea

Countries

South Korea

Other Identifiers

06-2012-208

Identifier Type: OTHER

Identifier Source: secondary_id

E-1209-170-002

Identifier Type: -

Identifier Source: org_study_id