Skin LaxityNCT01519206
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
A study testing Ulthera System Treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Ulthera System Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat on the cheeks
- Excessive skin laxity on the lower face and neck
- Significant scarring in areas to be treated
- Significant open facial wounds or lesions
- Severe or cystic acne on the face
- Presence of a metal stent or implant in the facial area to be treated, a pacemaker, or cochlear implants
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser & Skin Surgery Center of NY
New York, New York, 10016
About this study
Official title: Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
Read the detailed description
All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.
- Conditions
- Skin Laxity
- Being tested
- Ulthera System Treatment
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera System TreatmentDevice
Also called Ultherapy™, Ulthera, Inc., Ultrasound treatment for skin tightening
Focused ultrasound energy delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Ultherapy treatment | Experimental | Ulthera System Treatment Receives: Device: Ulthera System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Overall Lifting and Tightening of Skin
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
Measured: Baseline to 90 days post treatment
Secondary outcomes (3)
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
Measured: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment
Subjects' Assessment of Pain
Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.
Measured: During Ulthera treatment
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.
Measured: Baseline to 90 days, 180 days and 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roy Geronemus, M.D., Principal investigator, Laser & Skin Surgery Center of NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519206
- Sponsor's protocol ID
- ULT-124
- Status last verified
- Nov 2017
- First submitted
- 8 Dec 2011
- Last updated
- 11 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.
- ClinicalTrials.gov ID
- NCT01519206
- Acronym / sponsor ID
- ULT-124
- Conditions
- Skin Laxity
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Posted 2 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
Detailed description
All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultherapy treatment | Experimental | Device: Ulthera System TreatmentUlthera System Treatment |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 30 to 65 years
- Subject in good health
- Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Key exclusion criteria (8 listed)
- Presence of an active systemic or local skin disease that may affect wound healing
- Severe solar elastosis
- Excessive subcutaneous fat on the cheeks
- Excessive skin laxity on the lower face and neck
- Significant scarring in areas to be treated
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 |
|---|---|---|
| Ulthera System TreatmentAlso: Ultherapy™, Ulthera, Inc., Ultrasound treatment for skin tighteningFocused ultrasound energy delivered below the surface of the skin. | Device | Ultherapy treatment |
Primary outcome
Improvement in Overall Lifting and Tightening of Skin
Time frame: Baseline to 90 days post treatment
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
3 secondary outcomes
Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.
Time frame: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment
Subjects' Assessment of Pain
Time frame: During Ulthera treatment
Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment
Time frame: Baseline to 90 days, 180 days and 1 year post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roy Geronemus, M.D. principal investigator
Laser & Skin Surgery Center of NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera System Treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
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 5 inclusion and 8 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 11 Dec 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement in Overall Lifting and Tightening of Skin (time frame: Baseline to 90 days 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 11 Dec 2017.