Brachial PtosisNCT01713933

Evaluation of the Ulthera® System for Treatment of the Brachia

A study testing Ulthera® System in people with Brachial Ptosis, run by Ulthera, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Brachial Ptosis
What is being tested?: Ulthera® System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Jun 2011to May 2012
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 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female, aged 19 - 55 years.
Subject in good health.
Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
Mild to moderate laxity of the upper arm.
Mild to moderate subcutaneous fat of the upper arm.
Mild crepiness of the skin of the upper arm.
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.

Who cannot join

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the upper arm.
Excessive skin laxity in the upper arm.
Significant scarring in areas to be treated.
Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sasaki Advanced Aesthetic Medical Center
Pasadena, California, 91105

Other trials in United States

About this study

Official title: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia

Read the detailed description

This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Conditions: Brachial Ptosis
Being tested: Ulthera® System
Keywords: Ulthera® System, Ultherapy™ treatment, Ulthera, Inc.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ulthera® SystemDevice
Also called Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Focused ultrasound energy delivered below the surface of the skin.

Study groups in NCT01713933
Study group	Role	What they receive
Ultherapy™ treatment	Experimental	Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms Receives: Device: Ulthera® System

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
Measured: Baseline to 90 days post-treatment

Secondary outcomes (8)

Quantitative Improvement in Skin Laxity
Assess change in brachial volume based on brachial tissue measurements.
Measured: Baseline to 90 days post-treatment
Change in Dermal Thickness
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.
Measured: Baseline to 90 days post-treatment
Change in Dermal Thickness
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.
Measured: Baseline to180 days post-treatment
Overall Aesthetic Improvement
Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse
Measured: Baseline to 60 days post-treatment
Overall Aesthetic Improvement
Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse
Measured: Baseline to 90 days post-treatment
Overall Aesthetic Improvement
Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse
Measured: Baseline to180 days post-treatment
Patient Satisfaction
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.
Measured: Baseline to 90 days post-treatment
Patient Satisfaction
Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.
Measured: Baseline to 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.

Jun 2011May 2012

First posted25 Oct 2012 (estimated)
Study startJun 2011
Primary completionFeb 2012
Study completionMay 2012

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 Brachial 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01713933
Sponsor's protocol ID: ULT-114
Status last verified: Nov 2017
First submitted: 15 Oct 2012
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 Ulthera® System for Obtaining Lift and Tightening of the Brachia
ClinicalTrials.gov ID: NCT01713933
Acronym / sponsor ID: ULT-114
Conditions: Brachial Ptosis
Keywords: Ulthera® System, Ultherapy™ treatment, Ulthera, Inc.
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Feb 2012 (actual)
Study completion: May 2012 (actual)
First posted: 25 Oct 2012 (estimated)
Results: Posted 26 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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® SystemEach enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Male or female, aged 19 - 55 years.
Subject in good health.
Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
Mild to moderate laxity of the upper arm.
Mild to moderate subcutaneous fat of the upper arm.

Key exclusion criteria (6 listed)

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the upper arm.
Excessive skin laxity in the upper arm.
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® SystemAlso: Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tighteningFocused ultrasound energy delivered below the surface of the skin.	Device	Ultherapy™ treatment

Primary outcome

Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
Time frame: Baseline to 90 days post-treatment
Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.

8 secondary outcomes

Quantitative Improvement in Skin Laxity
Time frame: Baseline to 90 days post-treatment
Change in Dermal Thickness
Time frame: Baseline to 90 days post-treatment
Change in Dermal Thickness
Time frame: Baseline to180 days post-treatment
Overall Aesthetic Improvement
Time frame: Baseline to 60 days post-treatment
Overall Aesthetic Improvement
Time frame: Baseline to 90 days post-treatment
Overall Aesthetic Improvement
Time frame: Baseline to180 days post-treatment
Patient Satisfaction
Time frame: Baseline to 90 days post-treatment
Patient Satisfaction
Time frame: Baseline to 180 days post-treatment

Results and safety

Results posted to the registry on 26 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultherapy® Treatment	37	31

Primary outcome: Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity

Time frame: Baseline to 90 days post-treatment. Number. Unit: percentage of participants improved

Measure	Ultherapy® Treatment n = 27
Value	48

Population analysed: Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultherapy® Treatment	0 of 37 (0%)	0 of 37 (0%)	Not reported

Limitations and caveats (from the sponsor): \- Poor subject selection (high BMI with large volume arms enrolled rather than subjects with laxity and wrinkled skin)

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.

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.

Gordon Sasaki, MD FACS principal investigator

Sasaki Advanced Aesthetic Medical Center

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 in people with Brachial 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 8 inclusion and 6 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 26 May 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 Obtaining Lift and Tightening of Brachial Skin Laxity (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?

On the ClinicalTrials.gov record for NCT01713933.

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.