Facial Skin LaxityNCT01368965

Lifting and Tightening of the Face in Subjects With Skin of Darker Color

A study testing Ulthera® System treatment in people with Facial Skin Laxity, run by Ulthera, Inc at 2 sites in United States.

Completed

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

Official record

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Trial summary

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy… Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Facial 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: 54 participants
Where: 2 sitesUnited States
Study dates: Mar 2011to Aug 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 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 lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
Fitzpatrick skin phototypes of 3 through 6.
Provide written informed consent and HIPAA authorization

Who cannot join

Pregnant or lactating.
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat on the cheek.
Excessive skin laxity on the lower face and neck.
Significant scarring in areas to be treated.

Show all 9Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Harris Aesthetics, LLC
Chevy Chase, Maryland, 20815
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, 20852

Other trials in United States

About this study

Official title: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6

Read the detailed description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Conditions: Facial Skin Laxity
Being tested: Ulthera® System treatment

What participants receive

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

Ulthera® System treatmentDevice
Ulthera® System treatment delivering focused ultrasound energy

Study groups in NCT01368965
Study group	Role	What they receive
Ulthera® System treatment	Experimental	Not described Receives: Device: Ulthera® System treatment

What is being measured

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

Change in Overall Lifting and Tightening of Treated Tissue
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos
Measured: 90 days post treatment

Secondary outcomes (4)

Global Aesthetic Improvement at 90 Days Post-treatment
At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Measured: 90 Days post-treatment
Global Aesthetic Improvement at 180 Days Post-treatment
At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.
Measured: 180 days post-treatment
Patient Satisfaction Questionnaire
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
Measured: 90 Days post-treatment
Patient Satisfaction Questionnaire
Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.
Measured: 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.

Mar 2011Aug 2012

First posted8 Jun 2011 (estimated)
Study startMar 2011
Primary completionOct 2011
Study completionAug 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Facial 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01368965
Sponsor's protocol ID: ULT-112
Status last verified: Nov 2017
First submitted: 6 Jun 2011
Last updated: 13 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990.
PubMed 26313402

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
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All Facial Skin Laxity trials

Study at a glance

From the registry record, last updated by the sponsor on 13 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 Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6
ClinicalTrials.gov ID: NCT01368965
Acronym / sponsor ID: ULT-112
Conditions: Facial Skin Laxity
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Oct 2011 (actual)
Study completion: Aug 2012 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Posted 26 Mar 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: Single blind (outcomes assessor)
Number of arms: 1

Arm	Type	Receives
Ulthera® System treatment	Experimental	Device: Ulthera® 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.
Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
Fitzpatrick skin phototypes of 3 through 6.
Provide written informed consent and HIPAA authorization

Key exclusion criteria (9 listed)

Pregnant or lactating.
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat on the cheek.
Excessive skin laxity on the lower face and neck.

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 treatmentUlthera® System treatment delivering focused ultrasound energy	Device	Ulthera® System treatment

Primary outcome

Change in Overall Lifting and Tightening of Treated Tissue
Time frame: 90 days post treatment
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos

4 secondary outcomes

Global Aesthetic Improvement at 90 Days Post-treatment
Time frame: 90 Days post-treatment
Global Aesthetic Improvement at 180 Days Post-treatment
Time frame: 180 days post-treatment
Patient Satisfaction Questionnaire
Time frame: 90 Days post-treatment
Patient Satisfaction Questionnaire
Time frame: 180 days post-treatment

Results and safety

Results posted to the registry on 26 Mar 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
Treated Subjects	52	40

Primary outcome: Change in Overall Lifting and Tightening of Treated Tissue

Time frame: 90 days post treatment

Population analysed: Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site.

4 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
Enrolled Subjects	0 of 54 (0%)	0 of 54 (0%)	Not reported

Limitations and caveats (from the sponsor): Study Limitations: * Masked assessment was not completed as photos were not usable, i.e., poor image quality, positioning and timing. * Site staffing changes. * Overburdened site staff. * Poor photography quality * Subject selection

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26313402Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990.

Related trials for Facial Skin Laxity

Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Active, not recruiting
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Skin Laxity, Wrinkle
Recruiting
VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
Facial Skin Laxity
Recruiting
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
Wrinkle, Scar
Active, not recruiting
Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
Rhytids, Skin Laxity

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.

Hema Sundaram, M.D. principal investigator

Dermatology, Cosmetic & Laser Surgery

Monte O Harris, M.D. principal investigator

Harris Aesthetics, LLC

2 sites 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 Facial Skin Laxity, run by Ulthera, Inc at 2 sites 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 9 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 13 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 2 sites 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 Mar 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?

Change in Overall Lifting and Tightening of Treated Tissue (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?

On the ClinicalTrials.gov record for NCT01368965, which also lists 1 linked publication.

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 13 Dec 2017.