Skin LaxityNCT01708460
Feasibility Study: Ulthera Treatment of the Buttocks and Thighs
A study testing Ulthera System Treatment in people with Skin Laxity, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit. 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
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2013
- 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, age 30 to 65 years.
- Subject in good health.
- Skin laxity in the buttocks and thighs.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up 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.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing.
- BMI equal to or greater than 40.
- Excessive subcutaneous fat in the buttocks and thighs.
- Excessive skin laxity in the buttocks and thighs.
- Significant weight fluctuation (±10 lbs) in the past 6 months.
- Taking weight-loss medications/supplements.
- Surgical or non-surgical treatments to the target areas in the last 12 months, e.g., liposuction.
- Inability to understand the protocol or to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Laser and Surgery Specialist of New York and New Jersey
New York, New York, 10022
About this study
Official title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Read the detailed description
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
- Conditions
- Skin Laxity
- Being tested
- Ulthera System Treatment
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
- 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™
Focused ultrasound energy delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Ulthera-treated subjects | Experimental | All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body. Receives: Device: Ulthera System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall lifting and tightening of the buttocks and thighs.
As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
Measured: 90 days post-treatment
Secondary outcomes (2)
Overall aesthetic improvement.
As determined by GAIS completed by the Investigator and subject.
Measured: 90 and 180 days post-treatment.
Overall subject satisfaction.
As determined by subjects' completion of a Patient Satisfaction Questionnaire.
Measured: 90 and 180 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Goldberg, MD, Principal investigator, Skin Laser and Surgery Specialist of New York and New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708460
- Sponsor's protocol ID
- ULT-118
- Status last verified
- Sep 2013
- First submitted
- 15 Oct 2012
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs
- ClinicalTrials.gov ID
- NCT01708460
- Acronym / sponsor ID
- ULT-118
- Conditions
- Skin Laxity
- Keywords
- Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Oct 2012 (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.
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed description
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulthera-treated subjects | Experimental | Device: Ulthera System TreatmentAll enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age 30 to 65 years.
- Subject in good health.
- Skin laxity in the buttocks and thighs.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up 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.
- BMI equal to or greater than 40.
- Excessive subcutaneous fat in the buttocks and thighs.
- Excessive skin laxity in the buttocks and thighs.
- Significant weight fluctuation (±10 lbs) in the past 6 months.
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™Focused ultrasound energy delivered below the surface of the skin. | Device | Ulthera-treated subjects |
Primary outcome
Overall lifting and tightening of the buttocks and thighs.
Time frame: 90 days post-treatment
As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
2 secondary outcomes
Overall aesthetic improvement.
Time frame: 90 and 180 days post-treatment.
Overall subject satisfaction.
Time frame: 90 and 180 days post-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 24 Nov 2017.
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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.
David Goldberg, MD principal investigator
Skin Laser and Surgery Specialist of New York and New Jersey
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 6 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 24 Nov 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?
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?
Overall lifting and tightening of the buttocks and thighs. (time frame: 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 24 Nov 2017.