Nasolabial FoldNCT01775293
Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh
A study testing Non-absorbable polypropylene mesh in people with Nasolabial Fold, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- Non-absorbable polypropylene mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, Seongbukgu/Seoul, 136-705
About this study
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)
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)
Read the detailed description
- 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
- Being tested
- Non-absorbable polypropylene mesh
- Keywords
- Non-absorbable polypropylene mesh, WSRS, Rhytidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Non-absorbable polypropylene mesh | Experimental | 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 Receives: Device: Non-absorbable polypropylene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: change in the WSRS from baseline at7 week
Secondary outcomes (1)
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)
Measured: Changes Satisfaction from baseline at 7week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- D.med
- Responsible party
- Sponsor
- Investigators
- Chanyeong Heo, Master, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775293
- Sponsor's protocol ID
- E-1209-170-002
- Other IDs
- 06-2012-208
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01775293
- Acronym / sponsor ID
- E-1209-170-002
- Conditions
- Nasolabial Fold
- Keywords
- Non-absorbable polypropylene mesh, WSRS, Rhytidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- D.med
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-absorbable polypropylene mesh | Experimental | Device: Non-absorbable polypropylene mesh2 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-absorbable polypropylene mesh2 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 | Device | Non-absorbable polypropylene mesh |
Primary outcome
The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration
Time frame: change in the WSRS from baseline at7 week
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)
1 secondary outcome
The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration
Time frame: Changes Satisfaction from baseline at 7week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanyeong Heo, Master principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-absorbable polypropylene mesh in people with Nasolabial Fold, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration (time frame: change in the WSRS from baseline at7 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.