WrinklesNCT02368925
Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck
A study testing Ultherapy™ System in people with Wrinkles, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- Ultherapy™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Oct 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 30 to 65 years.
- Subject in good health
- Subjects who desire improvement in neck skin
Who cannot join
- Presence of an active systemic infectious disease
- general disease or skin disorder in the area to be treated
- Pregnant or lactating subjects
- Previous episode of facial or neck surgery for wrinkle correction
- Subjects who have aesthetic addiction, drug abuse, alcohol abuse
- Subjects who were treated Botox or Filler at the neck area
- Subjects who had Auto-Immune disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin
Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.
Read the detailed description
Before Treatment:
The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the FACE-Q Appraisal of Neck scale score
Treatment:
The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.
Post-Treatment:
All subjects will visit the Institution at 12 weeks from the day of procedure, and will take photos of the neck. Efficacy evaluation will performed by the Photographic Evaluator.
- Conditions
- Wrinkles
- Being tested
- Ultherapy™ System
- Keywords
- Rhytids, Skin Laxity
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultherapy™ SystemDevice
The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.
| Study group | Role | What they receive |
|---|---|---|
| Ultherapy™ System | Experimental | Ultherapy™ System Receives: Device: Ultherapy™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Assessment of Improvement at 12 weeks post-treatment
Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs
Measured: 12 weeks post-treatment
Secondary outcomes (2)
Subject Assessment of Improvement at 12 weeks post-treatment
Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks posttreatment
Measured: 12 weeks post-treatment
Subjects' Assessment of Pain during treatment
Pain score record using a Numeric Rating Scale (NRS,0-10) , with 0 representing no pain and 10 representing the worst pain possible.
Measured: Subjects were assessed for the duration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor
- Investigators
- ChangSik Pak, Bachelor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368925
- Sponsor's protocol ID
- E-1411/274-002
- Status last verified
- Apr 2016
- First submitted
- 15 Feb 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin
- ClinicalTrials.gov ID
- NCT02368925
- Acronym / sponsor ID
- E-1411/274-002
- Conditions
- Wrinkles
- Keywords
- Rhytids, Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Feb 2015 (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.
Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.
Detailed description
Before Treatment:
The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the FACE-Q Appraisal of Neck scale score
Treatment:
The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.
Post-Treatment:
All subjects will visit the Institution at 12 weeks from the day of procedure, and will take photos of the neck. Efficacy evaluation will performed by the Photographic Evaluator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultherapy™ System | Experimental | Device: Ultherapy™ SystemUltherapy™ System |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged 30 to 65 years.
- Subject in good health
- Subjects who desire improvement in neck skin
Key exclusion criteria (7 listed)
- Presence of an active systemic infectious disease
- general disease or skin disorder in the area to be treated
- Pregnant or lactating subjects
- Previous episode of facial or neck surgery for wrinkle correction
- Subjects who have aesthetic addiction, drug abuse, alcohol abuse
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 |
|---|---|---|
| Ultherapy™ SystemThe Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck. | Device | Ultherapy™ System |
Primary outcome
Investigator Assessment of Improvement at 12 weeks post-treatment
Time frame: 12 weeks post-treatment
Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs
2 secondary outcomes
Subject Assessment of Improvement at 12 weeks post-treatment
Time frame: 12 weeks post-treatment
Subjects' Assessment of Pain during treatment
Time frame: Subjects were assessed for the duration of study treatment
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 15 Apr 2016.
- Individual participant dataSharing planned: No
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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.
ChangSik Pak, Bachelor principal investigator
Seoul National University Bundang 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 Ultherapy™ System in people with Wrinkles, 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 7 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 15 Apr 2016. 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?
Investigator Assessment of Improvement at 12 weeks post-treatment (time frame: 12 weeks post-treatment). 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 15 Apr 2016.