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

Nasolabial Fold Clinical Trial

Official title:

A Multi Center, Non-comparative Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety After Rhytidectomy Using Non-absorbable Mesh(RPM)

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

• Nasolabial Fold

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