Clinical trial NCT01775293: Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold
Keywords: Non-absorbable polypropylene mesh
WSRS
Rhytidectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: D.med
First posted: 2013-01-24
Enrollment: 28
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration
timeFrame: change in the WSRS from baseline at7 week
Secondary outcomes:
measure: The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration
timeFrame: Changes Satisfaction from baseline at 7week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbukgu/Seoul
Study officials:
affiliation: Seoul National University Hospital
name: Chanyeong Heo, Master
role: PRINCIPAL_INVESTIGATOR
References: