Mild to Moderate Skin Laxity Under the ChinULT-302NCT03351335

Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients

A study testing Microfocused ultrasound with visualization in people with Mild to Moderate Skin Laxity Under the Chin and Mild to Moderate Skin Laxity on Neck, run by Merz North America, Inc. at 7 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

To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients Read more about this study

Who is it for?: Ages 35 to 65 years
Conditions the study is for: Mild to Moderate Skin Laxity Under the Chin, Mild to Moderate Skin Laxity on Neck
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: 60 participants
Where: 7 sitesUnited States
Study dates: 10 Aug 2017to 9 Aug 2018
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 35 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Both parents of full Chinese decent.
Mild to moderate skin laxity of the submental (under the chin) and neck tissue as determined by the physician and trained assessors.
Adequate menton area to allow for quantitative analysis, as confirmed by photography images.
Willingness and ability to comply with protocol requirements, including returning for follow-up visit and abstaining from any other procedures in the areas to be treated through the follow-up period.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening 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 with last menstrual bleeding at least 12 months prior to study; and

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Without a uterus and/or both ovaries.
Willing to take 600mg Ibuprofen as pre-treatment medication, at least 60 minutes but not more than two hours prior to study treatment.
Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
Willingness and ability to provide written informed consent prior to performance of any study-related procedure.

Who cannot join

Presence of an active systemic or local skin disease that may affect wound healing.
Presence of any hemorrhagic disorder or hemostatic dysfunction, herpes simplex, diabetes, epilepsy, bell's palsy or any physical or psychological condition that is deemed unacceptable by the investigator for participation in this study.
Severe solar elastosis.
Excessive subcutaneous fat in the area(s) to be treated.
Excessive skin laxity on the area(s) to be treated.
Significant scarring in the area(s) to be treated that would interfere with assessing results.

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Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) to be treated.
Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
Inability to understand the protocol or to give informed consent.
Allergy or sensitivity to pre-treatment medication (ibuprofen).
Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
BMI greater than or equal to 30.
History of chronic drug or alcohol abuse.
More than 2-3 doses of any NSAID in any 2-week period prior to and throughout study.
History of autoimmune disease.
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 or enrollment in any study involving the use of investigational devices or drugs within the past three months.
Current smoker as defined by
Having smoked one or more cigarettes per day on a daily basis within the past year; or
Smoke cessation within the past 6 months.
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(s) to be treated:
Skin tightening procedure within the past year;
Injectable filler of any type within the past: i) 9 months for Hyaluronic acid fillers (e.g. Restylane); ii) 24 months for Ca Hydroxyapatite fillers (e.g. Radiesse); iii) 12 months for Long-lasting Hyaluronic acid (Juvéderm Voluma); iv) 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra); v) Ever for permanent fillers (e.g. Silicone, Artecoll)
Neurotoxins within the past three months;
Ablative resurfacing laser treatment;
Nonablative, rejuvenative laser or light treatment within the past six months;
Surgical dermabrasion or deep facial peels;
Facelifts within the past year; or
Any history of contour threads.
History (in the prior year) or current use of the following prescription medications:
Accutane or other systemic retinoids within the past six months;
Topical Retinoids within the past two 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

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Merz Investigational Site # 0010410
Austin, Texas, 78745
Merz Investigational Site # 0010422
Bellaire, Texas, 77401
Merz Investigational Site # 0010423
Houston, Texas, 77056
Merz Investigational Site # 0010411
Los Gatos, California, 95032
Merz Investigational Site # 0010125
Plano, Texas, 75093
Merz Investigational Site # 0010321
San Diego, California, 92121
Merz Investigational Site # 0010358
Vista, California, 92083

Other trials in United States

About this study

To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients

Conditions: Mild to Moderate Skin Laxity Under the Chin, Mild to Moderate Skin Laxity on Neck
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®
All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.

Study groups in NCT03351335
Study group	Role	What they receive
Ultherapy®, energy level 3	Experimental	Group 1: Subjects will receive Ultherapy® treatment at energy level 3 (EL3). Receives: Device: Microfocused ultrasound with visualization
Ultherapy®, energy level 4	Experimental	Group 2: Subjects will receive Ultherapy® treatment at energy level 4 (EL4). Receives: Device: Microfocused ultrasound with visualization
Ultherapy®, energy level 2	Experimental	Group 3: Subjects will receive Ultherapy® treatment at energy level 2 (EL2). Receives: Device: Microfocused ultrasound with visualization

What is being measured

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

Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment
Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.
Measured: Baseline and Day 90

Secondary outcomes (4)

Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Physician Global Aesthetic Improvement Scale (PGAIS) Scores at Day 90 Post-treatment
Overall aesthetic improvement was assessed by a principal investigator using global aesthetic improvement scale (GAIS).The PGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the physician. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement was determined by participant response rate (improved or much improved) on PGAIS.
Measured: Day 90
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 Post-treatment
Overall aesthetic improvement was assessed by a principal investigator using GAIS. The SGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the participant. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement is determined by participant response rate (improved or much improved) on SGAIS.
Measured: Day 90
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
Masked, qualitative photographic assessment of photographs were obtained using Mirror Photofile software and a Vectra 3D digital imaging system. Experienced physicians evaluated paired pre- and 90-days post-treatment photographs of evaluable participants in a blinded fashion. Each blinded assessor reviewed the image sets and identified the post-treatment photographs according to the following definitions: Change (A change that is noticeable) and No Change (No change is apparent). Blinded assessors were asked to compare pre- and post-treatment photos for noticeable change. When change was noted the assessors were asked to determine which image demonstrated improvement. Assessor data were compiled and analyzed using majority rule for each participant assessed.
Measured: Day 90
Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment
Participant satisfaction was determined by scores on PSQ completed at 90 days post-treatment. The participant completed this assessment while referring to baseline photos on a sponsor-supplied electronic tablet and a hand mirror. Participants were requested to provide information on "Please indicate what you think about how the treated areas of your lower face and neck look today. With your face relaxed (do not smile), look in the mirror at the treated area on both sides of your face and compare to the photos taken of both sides of your face prior to your study treatment." First questionnaire was as "Compared to when you started the study, how do your lower face, under your chin, and your upper neck look today?" Improved (much improved, improved, little improved), no change, worse. Second questionnaire was "How would you characterize your satisfaction with the treatment?" Satisfied (extremely satisfied, satisfied, slightly satisfied), neither satisfied or dissatisfied, dissatisfied.
Measured: Day 90

Timeline

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

10 Aug 20179 Aug 2018

First posted22 Nov 2017
Study start10 Aug 2017
Primary completion9 Aug 2018
Study completion9 Aug 2018

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 Mild to Moderate Skin Laxity Under the ChinStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03351335
Sponsor's protocol ID: M960001052
Acronym: ULT-302
Status last verified: Aug 2018
First submitted: 20 Nov 2017
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
ClinicalTrials.gov ID: NCT03351335
Acronym / sponsor ID: ULT-302 / M960001052
Conditions: Mild to Moderate Skin Laxity Under the Chin, Mild to Moderate Skin Laxity on Neck
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Merz North America, Inc.Industry (pharma, biotech, devices)
Collaborators: Ulthera, Inc
Study start: 10 Aug 2017 (actual)
Primary completion: 9 Aug 2018 (actual)
Study completion: 9 Aug 2018 (actual)
First posted: 22 Nov 2017 (actual)
Results: Posted 28 Aug 2019

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 Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ultherapy®, energy level 3	Experimental	Device: Microfocused ultrasound with visualizationGroup 1: Subjects will receive Ultherapy® treatment at energy level 3 (EL3).
Ultherapy®, energy level 4	Experimental	Device: Microfocused ultrasound with visualizationGroup 2: Subjects will receive Ultherapy® treatment at energy level 4 (EL4).
Ultherapy®, energy level 2	Experimental	Device: Microfocused ultrasound with visualizationGroup 3: Subjects will receive Ultherapy® treatment at energy level 2 (EL2).

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Both parents of full Chinese decent.
Mild to moderate skin laxity of the submental (under the chin) and neck tissue as determined by the physician and trained assessors.
Adequate menton area to allow for quantitative analysis, as confirmed by photography images.
Willingness and ability to comply with protocol requirements, including returning for follow-up visit and abstaining from any other procedures in the areas to be treated through the follow-up period.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening 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:

Key exclusion criteria (39 listed)

Presence of an active systemic or local skin disease that may affect wound healing.
Presence of any hemorrhagic disorder or hemostatic dysfunction, herpes simplex, diabetes, epilepsy, bell's palsy or any physical or psychological condition that is deemed unacceptable by the investigator for participation in this study.
Severe solar elastosis.
Excessive subcutaneous fat in the area(s) to be treated.
Excessive skin laxity on the area(s) 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
Microfocused ultrasound with visualizationAlso: Ultherapy®All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.	Device	Ultherapy®, energy level 2, Ultherapy®, energy level 3, Ultherapy®, energy level 4

Primary outcome

Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment
Time frame: Baseline and Day 90
Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.

4 secondary outcomes

Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Physician Global Aesthetic Improvement Scale (PGAIS) Scores at Day 90 Post-treatment
Time frame: Day 90
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 Post-treatment
Time frame: Day 90
Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment
Time frame: Day 90
Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment
Time frame: Day 90

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group EL 2: Ultherapy	21	21
Group EL 3: Ultherapy	19	19
Group EL 4: Ultherapy	20	16

Primary outcome: Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment

Time frame: Baseline and Day 90. Mean (Standard Deviation). Unit: square millimeter (mm^2)

Measure	Group EL 2: Ultherapy n = 21	Group EL 3: Ultherapy n = 19	Group EL 4: Ultherapy n = 16
Value	-14.4 (28.0)	-7.9 (40.8)	-22.3 (38.2)

Population analysed: The full analysis set (FAS) population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 90. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group EL 2: Ultherapy	0 of 21 (0%)	7 of 21 (33.3%)	0 of 21
Group EL 3: Ultherapy	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
Group EL 4: Ultherapy	0 of 20 (0%)	3 of 20 (15%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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.

Peter Kreymerman, MD, FA study director

Merz North America, Inc.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 39 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 28 Aug 2019). 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?

Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment (time frame: Baseline and Day 90). 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 NCT03351335.

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 28 Aug 2019.