Buttock PtosisNCT02270892
Ultherapy for Buttock Lift
A study testing Ulthera treatment in people with Buttock Ptosis, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera® treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the last 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 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Buttock Ptosis
- What is being tested?
- Ulthera treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2014to 3 Apr 2017
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, age 18 to 65 years.
- Subject in good health.
- Mild to moderate buttock ptosis based on Investigator evaluation.
- BMI <25.
- No history of weight gain or loss of greater than 10 pounds within the past year.
- No planned weight loss or gain for the duration of the study.
Show all 22Show fewer
- No pregnancy within the past year.
- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. If a chronic user, a washout period of 4 weeks is required prior to study treatment #1. Washout period for limited acute NSAID use, i.e., a maximum of 2-3 doses, is required in the 2 weeks prior to any study treatment visit.
- No immunosuppressive therapy, e.g., oral steroid treatment, within the past 4 weeks and during the entire post-treatment study period. Washout period, if recent use, for 4 weeks prior to study treatment #1.
- Subject must desire improvement of her buttock ptosis as demonstrated by a Dissatisfaction response on a baseline Patient Satisfaction Questionnaire, i.e., Dissatisfied, Neither Satisfied or Dissatisfied, Slightly Satisfied, Satisfied, Very Satisfied.
- Willingness to refrain from receiving spray tans or using self-tanning lotions from mid-thigh to waist within 2 weeks of any study assessments for the duration of the trial.
- Willingness to avoid as much as possible, direct and prolonged sun exposure from mid-thigh to waist for the duration of the study.
- Willingness to refrain from topical steroid use, tretinoin, caffeine cream and other prescription or over-the-counter cellulite reduction topicals to the affected area 2 weeks prior to study treatment #1 and for the duration of the study period.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated 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 the Baseline Visit 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:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness and ability to provide written consent for study-required photography and adherence to photography procedures.
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Who cannot join
- Radiofrequency, CoolSculpting, liposuction, other energy-based treatment in the area to be treated for body contouring, fat reduction, improvement of cellulite, or reduction of buttock ptosis within 1 year prior to study participation or during the study.
- Short-wave or massage therapy in the area to be treated for treatment of cellulite or buttock ptosis within 3 months prior to study participation or during the study.
- BMI greater than or equal to 25.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Excessive subcutaneous fat in the area to be treated.
- Excessive skin laxity on the area to be treated.
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- Severe buttock ptosis.
- Significant scarring or tattoos in the area to be treated that would interfere with assessing results.
- Open wounds or lesions in the area to be treated.
- Inability to understand the protocol or to give informed consent.
- History of chronic drug or alcohol abuse.
- History of autoimmune disease.
- Has a known allergy or a known contraindication to ketorolac tromethamine (Toradol).
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last 5 years.
- Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- History of the following cosmetic treatments in the area to be treated:
- Skin tightening procedure within the past year;
- Buttock implants;
- Buttock fillers (e.g., silicone, semi-permanent or permanent fillers or autologous fat injections);
- Fat emulsifiers;
- Injections for the treatment of cellulite.
- History of using the following prescription medications:
- Accutane or other systemic retinoids within the past 6 months;
- Topical retinoids, tretinoin, caffeine cream and other prescription or over-the-counter cellulite reduction topicals within the past 2 weeks;
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
La Jolla, California, 92121
About this study
Official title: Evaluation of the Ulthera® System for Lifting of the Buttock
Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera® treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the last treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Read the detailed description
This study is a prospective, single-blinded, randomized, split-body clinical study to be conducted at one clinical site. Investigator will assess baseline buttock ptosis to confirm subject eligibility.
Enrolled subjects meeting all entrance criteria and who are confirmed to be eligible for study treatment will be randomized/assigned into one of two treatment groups: "Right side treated" and "Left side treated". All subjects will receive two, single-sided, dual-depth Ultherapy® treatments using the 4-4.5mm and 7-3.0mm transducers at 0.90J and 0.30J, respectively. Standardized images will be taken using standard 2D and Vectra 3D digital imaging systems. Subjects completing all study visits will be given the option of receiving two balancing treatments, 90 days apart, and will be required to complete one study visit at 90 days following the last balancing treatment. Quantititative and qualititative assessment of pre- versus post-treatment buttock ptosis will be completed for each post-treatment time point. Subjects will also complete a questionnaire at each study visit.
- Conditions
- Buttock Ptosis
- Being tested
- Ulthera treatment
- Keywords
- Ulthera, Ulthera System, Ultherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera treatmentDevice
Also called Ultherapy, Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Left side Ulthera treatment Receives: Device: Ulthera treatment |
| Group B | Active comparator | Right side Ulthera treatment Receives: Device: Ulthera treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day quantitative buttock lift
Post-treatment change from baseline in protocol-defined buttock measurements:
- ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh;
- β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.
Measured: 90 days following last treatment
180-day quantitative buttock lift
Post-treatment change from baseline in protocol-defined buttock measurements:
- ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh;
- β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.
Measured: 180 days following last treatment
270-day quantitative buttock lift
Post-treatment change from baseline in protocol-defined buttock measurements:
- ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh;
- β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.
Measured: 270 days following last treatment
Secondary outcomes (16)
90-day qualitative improvement in buttock ptosis
Determined by a masked, qualitative assessment of 2D photographs compared to baseline.
Measured: 90 days following last treatment
180-day qualitative improvement in buttock ptosis
Determined by a masked, qualitative assessment of 2D photographs compared to baseline.
Measured: 180 days following last treatment
270-day qualitative improvement in buttock ptosis
Determined by a masked, qualitative assessment of 2D photographs compared to baseline.
Measured: 270 days following last treatment
90-day Clinician Buttock Improvement Scale (CBIS)
CBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 90 days following last treatment
180-day Clinician Buttock Improvement Scale (CBIS)
CBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 180 days following last treatment
270-day Clinician Buttock Improvement Scale (CBIS)
CBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 270 days following last treatment
90-day Subject Buttock Improvement Scale (SBIS)
SBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 90 days following last treatment
180-day Subject Buttock Improvement Scale (SBIS)
SBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 180 days following last treatment
270-day Subject Buttock Improvement Scale (SBIS)
SBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 270 days following last treatment
90-day Patient Satisfaction Questionnaire (PSQ)
Patient satisfaction with treatment assessed based on completion of a PSQ.
Measured: 90 days following last treatment
180-day Patient Satisfaction Questionnaire (PSQ)
Patient satisfaction with treatment assessed based on completion of a PSQ.
Measured: 180 days following last treatment
270-day Patient Satisfaction Questionnaire (PSQ)
Patient satisfaction with treatment assessed based on completion of a PSQ.
Measured: 270 days following last treatment
Balancing treatment 90-day Patient Satisfaction Questionnaire (PSQ)
Patient satisfaction with treatment assessed based on completion of a PSQ.
Measured: 90 days following last balancing treatment
Balancing treatment 90-day Subject Buttock Improvement Scale (SBIS)
SBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 90 days following last balancing treatment
Balancing treatment 90-day Clinician Buttock Improvement Scale (CBIS)
CBIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:
- 1=very much improved
- 2=much improved
- 3=improved
- 4=no change
- 5=worse
Measured: 90 days following last balancing treatment
Balancing treatment 90-day quantitative buttock lift
Post-treatment change from baseline in protocol-defined buttock measurements:
- ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh;
- β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.
Measured: 90 days following last balancing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start28 Aug 2014
- Primary completion22 Jul 2016
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buttock PtosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Misell, PhD, Study director, Ulthera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270892
- Sponsor's protocol ID
- ULT-142
- Status last verified
- May 2017
- First submitted
- 17 Oct 2014
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ulthera® System for Lifting of the Buttock
- ClinicalTrials.gov ID
- NCT02270892
- Acronym / sponsor ID
- ULT-142
- Conditions
- Buttock Ptosis
- Keywords
- Ulthera, Ulthera System, Ultherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2014 (actual)
- Primary completion
- 22 Jul 2016 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 21 Oct 2014 (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 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera® treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the last treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed description
This study is a prospective, single-blinded, randomized, split-body clinical study to be conducted at one clinical site. Investigator will assess baseline buttock ptosis to confirm subject eligibility.
Enrolled subjects meeting all entrance criteria and who are confirmed to be eligible for study treatment will be randomized/assigned into one of two treatment groups: "Right side treated" and "Left side treated". All subjects will receive two, single-sided, dual-depth Ultherapy® treatments using the 4-4.5mm and 7-3.0mm transducers at 0.90J and 0.30J, respectively. Standardized images will be taken using standard 2D and Vectra 3D digital imaging systems. Subjects completing all study visits will be given the option of receiving two balancing treatments, 90 days apart, and will be required to complete one study visit at 90 days following the last balancing treatment. Quantititative and qualititative assessment of pre- versus post-treatment buttock ptosis will be completed for each post-treatment time point. Subjects will also complete a questionnaire at each study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ulthera treatmentLeft side Ulthera treatment |
| Group B | Active comparator | Device: Ulthera treatmentRight side Ulthera treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female, age 18 to 65 years.
- Subject in good health.
- Mild to moderate buttock ptosis based on Investigator evaluation.
- BMI <25.
- No history of weight gain or loss of greater than 10 pounds within the past year.
Key exclusion criteria (30 listed)
- Radiofrequency, CoolSculpting, liposuction, other energy-based treatment in the area to be treated for body contouring, fat reduction, improvement of cellulite, or reduction of buttock ptosis within 1 year prior to study participation or during the study.
- Short-wave or massage therapy in the area to be treated for treatment of cellulite or buttock ptosis within 3 months prior to study participation or during the study.
- BMI greater than or equal to 25.
- Presence of an active systemic or local skin disease that may affect wound healing.
- Excessive subcutaneous fat in the area 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 treatmentAlso: Ultherapy, Ulthera System TreatmentFocused ultrasound energy delivered below the surface of the skin | Device | Group A, Group B |
Primary outcome
90-day quantitative buttock lift
Time frame: 90 days following last treatment
Post-treatment change from baseline in protocol-defined buttock measurements: * ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh; * β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.
180-day quantitative buttock lift
Time frame: 180 days following last treatment
Post-treatment change from baseline in protocol-defined buttock measurements: * ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh; * β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.
270-day quantitative buttock lift
Time frame: 270 days following last treatment
Post-treatment change from baseline in protocol-defined buttock measurements: * ϒ (gamma) angle: The angle between the turning point between the gluteal sulcus line and the thigh; * β (beta) angle: The angle from the midpoint of the lateral thigh along the gluteal-sulcus line and the most posterior point of the buttock.
16 secondary outcomes
90-day qualitative improvement in buttock ptosis
Time frame: 90 days following last treatment
180-day qualitative improvement in buttock ptosis
Time frame: 180 days following last treatment
270-day qualitative improvement in buttock ptosis
Time frame: 270 days following last treatment
90-day Clinician Buttock Improvement Scale (CBIS)
Time frame: 90 days following last treatment
180-day Clinician Buttock Improvement Scale (CBIS)
Time frame: 180 days following last treatment
270-day Clinician Buttock Improvement Scale (CBIS)
Time frame: 270 days following last treatment
90-day Subject Buttock Improvement Scale (SBIS)
Time frame: 90 days following last treatment
180-day Subject Buttock Improvement Scale (SBIS)
Time frame: 180 days following last treatment
270-day Subject Buttock Improvement Scale (SBIS)
Time frame: 270 days following last treatment
90-day Patient Satisfaction Questionnaire (PSQ)
Time frame: 90 days following last treatment
180-day Patient Satisfaction Questionnaire (PSQ)
Time frame: 180 days following last treatment
270-day Patient Satisfaction Questionnaire (PSQ)
Time frame: 270 days following last treatment
Balancing treatment 90-day Patient Satisfaction Questionnaire (PSQ)
Time frame: 90 days following last balancing treatment
Balancing treatment 90-day Subject Buttock Improvement Scale (SBIS)
Time frame: 90 days following last balancing treatment
Balancing treatment 90-day Clinician Buttock Improvement Scale (CBIS)
Time frame: 90 days following last balancing treatment
Balancing treatment 90-day quantitative buttock lift
Time frame: 90 days following last balancing 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 31 Jan 2018.
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.
Lisa Misell, PhD study director
Ulthera, Inc
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 treatment in people with Buttock Ptosis, 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 22 inclusion and 30 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 31 Jan 2018. 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?
90-day quantitative buttock lift (time frame: 90 days following last treatment). The study lists 3 primary outcomes in all. 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 31 Jan 2018.