Facial Skin LaxityULT-215NCT03545412

Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

A study testing Microfocused ultrasound with visualization in people with Facial Skin Laxity, run by Ulthera, Inc.

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

To evaluate the effect of the Ulthera® system for facial laxity and sagging skin Read more about this study

Who is it for?: Ages 39 to 65 years
Conditions the study is for: Facial Skin Laxity
What is being tested?: Microfocused ultrasound with visualization
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: No sites listed yet
Study dates: 10 Jan 2014to 20 Aug 2014
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 39 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing to sign a written consent form
Willing to have of facial skin laxity and wrinkles assessed by clinician
Male or female, aged 39 to 65 years.
Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Who cannot join

Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) to be treated.
Presence of an active systemic or local skin disease that may affect wound healing.
Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
Subcutaneous fillers
Keloid scar

Show all 9Show fewer

Patients with anticoagulant treatment plan.
Children, pregnant women, breastfeeding women.
Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)

About this study

Official title: Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity

To evaluate the effect of the Ulthera® system for facial laxity and sagging skin

Conditions: Facial Skin Laxity
Being tested: Microfocused ultrasound with visualization

What participants receive

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

Microfocused ultrasound with visualizationDevice
Also called Ultherapy
Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths

Study groups in NCT03545412
Study group	Role	What they receive
Microfocused ultrasound with visualization	Experimental	Not described Receives: Device: Microfocused ultrasound with visualization

What is being measured

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

Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90
Lift improvement as measured by quantitative analysis was considered greater than or equal to (>=) 20.0 square millimeter (mm^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest.
Measured: Baseline, Day 90
Number of Participants With Lift in Brow Region at Day 90
Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area.
Measured: Baseline, Day 90

Secondary outcomes (5)

Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90
Overall aesthetic improvement was assessed by the principal investigator using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each principal investigator completed a GAIS, known as physician global aesthetic improvement scale (PGAIS) .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Measured: Baseline, Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Overall aesthetic improvement was assessed by participants using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each participant completed a GAIS, known as SGAIS.The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Measured: Baseline, Day 90
Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90
Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.
Measured: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180
Overall aesthetic improvement was assessed by the principal investigator using the GAIS. At 180 days post-treatment, each principal investigator completed a GAIS, known as PGAIS .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Measured: Baseline, Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180
Overall aesthetic improvement was assessed by participants using GAIS. At 180 days post-treatment, each participant completed a GAIS, known as SGAIS. The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.
Measured: Baseline, Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 201420 Aug 2014

First posted4 Jun 2018
Study start10 Jan 2014
Primary completion20 May 2014
Study completion20 Aug 2014

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: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03545412
Sponsor's protocol ID: ULT-215
Acronym: ULT-215
Status last verified: May 2018
First submitted: 22 May 2018
Last updated: 12 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Lu PH, Yang CH, Chang YC. Quantitative Analysis of Face and Neck Skin Tightening by Microfocused Ultrasound With Visualization in Asians. Dermatol Surg. 2017 Nov;43(11):1332-1338. doi: 10.1097/DSS.0000000000001181.
PubMed 28945618

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?

Official record

Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
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Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Skin Laxity, Wrinkle
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VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
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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

All Facial Skin Laxity trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity
ClinicalTrials.gov ID: NCT03545412
Acronym / sponsor ID: ULT-215 / ULT-215
Conditions: Facial Skin Laxity
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Ulthera, IncIndustry (pharma, biotech, devices)
Study start: 10 Jan 2014 (actual)
Primary completion: 20 May 2014 (actual)
Study completion: 20 Aug 2014 (actual)
First posted: 4 Jun 2018 (actual)
Results: Posted 12 Dec 2018

Clinical summary

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

To evaluate the effect of the Ulthera® system for facial laxity and sagging skin

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Microfocused ultrasound with visualization	Experimental	Device: Microfocused ultrasound with visualization

Who may qualify

Ages: 39 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Willing to sign a written consent form
Willing to have of facial skin laxity and wrinkles assessed by clinician
Male or female, aged 39 to 65 years.
Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).

Key exclusion criteria (9 listed)

Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) to be treated.
Presence of an active systemic or local skin disease that may affect wound healing.
Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
Subcutaneous fillers

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
Microfocused ultrasound with visualizationAlso: UltherapyEach subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths	Device	Microfocused ultrasound with visualization

Primary outcome

Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90
Time frame: Baseline, Day 90
Lift improvement as measured by quantitative analysis was considered greater than or equal to (>=) 20.0 square millimeter (mm^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest.
Number of Participants With Lift in Brow Region at Day 90
Time frame: Baseline, Day 90
Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area.

5 secondary outcomes

Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90
Time frame: Baseline, Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Time frame: Baseline, Day 90
Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90
Time frame: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180
Time frame: Baseline, Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180
Time frame: Baseline, Day 180

Results and safety

Results posted to the registry on 12 Dec 2018, 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	25	25

Primary outcome: Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90

Time frame: Baseline, Day 90. Count of participants. Unit: Participants

Measure	Ultherapy Treatment n = 13
Value	8

Population analysed: All participants enrolled and treated with Ultherapy. Only participants categorized as good candidates for photographs were included in the analysis. Good candidates for photographs was defined as those participants who had sufficient distance between the menton and neck, and enough lower face volume to allow for accurate measurements.

Primary outcome: Number of Participants With Lift in Brow Region at Day 90

Time frame: Baseline, Day 90. Count of participants. Unit: Participants

Measure	Ultherapy Treatment n = 24
Value	12

Population analysed: All participants who were treated with Ultherapy were included for the assessment. The analysis included all participants who had the measurement available for brows. One participant excluded due to inability to measure brow.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 180. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultherapy Treatment	0 of 25 (0%)	19 of 25 (76%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28945618Lu PH, Yang CH, Chang YC. Quantitative Analysis of Face and Neck Skin Tightening by Microfocused Ultrasound With Visualization in Asians. Dermatol Surg. 2017 Nov;43(11):1332-1338. doi: 10.1097/DSS.0000000000001181.
Individual participant dataSharing planned: No

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.

Merz Medical Expert study director

Merz North America, Inc.

Questions about this trial

What is this clinical trial studying?

A study testing Microfocused ultrasound with visualization in people with Facial Skin Laxity, run by Ulthera, Inc.

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 7 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 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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 12 Dec 2018). 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?

Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90 (time frame: Baseline, Day 90). The study lists 2 primary outcomes in all. 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 NCT03545412, 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 12 Dec 2018.