Skin LaxityNCT02416076
Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers
A study testing Ulthera Treatment at EL2 and Ulthera Treatment at EL4 in people with Skin Laxity, run by Ulthera, Inc at 3 sites in United States.
Trial summary
Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Ulthera Treatment at EL2 and Ulthera Treatment at EL4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Dec 2014to Jan 2016
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 30 to 65 years.
- Participant in good health.
- Skin laxity on the area(s) to be treated.
- 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.
- Participants 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 (example barrier methods used with a spermicidal agent, hormonal methods, intrauterine device (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:
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- 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 to refrain from use of aspirin, Ibuprofen, Naproxen or any other nonsteroidal anti-inflammatory drug (NSAID) prior to each study treatment and chronic use during the entire posttreatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. Washout period for limited acute NSAID use, that is, a maximum of 2-3 doses, is required in the 2 weeks prior to any study treatment visit.
- Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (that is, removal of jewelry and makeup).
- Willingness and ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization 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.
- 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.
- Open wounds or lesions in the area(s) to be treated.
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- Severe or cystic acne on the area(s) to be treated.
- Active implants (example, pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included).
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two 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 equal to or greater than 25.
- History of chronic drug or alcohol abuse.
- 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.
- Participants who anticipate the need for surgery or overnight hospitalization during the study.
- Participants 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 five years.
- Current user of any nicotine-containing products, example, electronic cigarettes (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.12 months for Hyaluronic acid fillers (example Rstylane)
- ii.12 months for Ca Hydroxyapatite fillers (example Radiesse)
- 24 months for Poly-L-Lactic acid fillers (example Sculptra)
- Ever for permanent fillers (example Silicone, ArteFill)
- Neurotoxins within the past six months; d. Ablative resurfacing laser treatment; e. Nonablative, rejuvenative laser or light treatment within the past six months; f. Surgical dermabrasion or deep facial peels; g. Facelifts, blepharoplasty, or browlift within the past 18 months; or h. Any history of contour threads.
- History of using 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 participant from understanding the protocol requirements or understanding and signing the informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Testing of Beverly Hills
Beverly Hills, California, 90210
California Skin Institute - Saratoga
Saratoga, California, 95070
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
About this study
Official title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Using Standard Transducers Versus Simulines Transducers
Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Read the detailed description
This is a prospective, multi-center, split-face, randomized pilot trial to determine the clinical feasibility of the Ulthera System prototype simulines transducers, that is, transducers which deliver two lines of treatment simultaneously (at once), in comparison to the standard transducers which deliver a single treatment line, by collecting average pain scores in the treated regions, as well as efficacy and treatment efficiency data. There will be 3 study arms with each arm having 2 treatment groups. Enrolled participants will be randomized to one of two study arms, and one of two treatment groups within each study arm.to determine which side of the face will be treated with Ulthera System standard transducers and Ulthera System prototype simulines transducers and the energy level for treatment. Participants will receive one dual-depth treatment at 4.5 millimeter (mm) and 3.0mm depths.
Clinical feasibility will be assessed based on comfort level of standard transducers versus simulines transducers by comparing average pain scores obtained during study treatment. Efficacy will be determined based on qualitative masked assessment of post-treatment photographs compared to pre-treatment photographs and quantitative eyebrow lift measurements. Patient satisfaction questionnaires will be obtained.
- Conditions
- Skin Laxity
- Being tested
- Ulthera Treatment at EL2, Ulthera Treatment at EL4
- Keywords
- Ulthera® System, Ultherapy®, Ulthera, Inc.
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera Treatment at EL2Device
Also called Ultherapy
Focused ultrasound energy delivered below the surface of the skin.
Ulthera Treatment at EL4Device
Also called Ultherapy
Focused ultrasound energy delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Group A - LT side simulines Ulthera treatment at EL2 | Active comparator | Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at the default Energy Level [EL2]. Receives: Device: Ulthera Treatment at EL2 |
| Group B - RT side simulines Ulthera treatment at EL2 | Active comparator | Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFT side of the face at the default Energy Level [EL2] . Receives: Device: Ulthera Treatment at EL2 |
| Group C - LT side simulines Ulthera treatment at EL4 | Active comparator | Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at a higher Energy Level [EL4]. Receives: Device: Ulthera Treatment at EL4 |
| Group D - RT side simulines Ulthera treatment at EL4 | Active comparator | Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFT side of the face at a higher Energy Level [EL4] . Receives: Device: Ulthera Treatment at EL4 |
| Group E - LT side simulines/standard Ulthera treatment at EL4 | Active comparator | Ulthera treatment using a 4-4.5 'Ulthera System, prototype simulines transducers' and 7-3.0 'Ulthera System, standard transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at a higher Energy Level [EL4]. Receives: Device: Ulthera Treatment at EL4 |
| Group F - RT side simulines/standard Ulthera treatment at EL4 | Active comparator | Ulthera treatment using a 4-4.5 'Ulthera System, prototype simulines transducers'and 7-3.0 standard transducer on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFTof the face at a higher Energy Level [EL4]. Receives: Device: Ulthera Treatment at EL4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort level of standard transducers versus simulines transducers during Ultherapy® treatment
Subjects' treatment-related pain scores will be obtained using a validated 0-10 point Numeric Rating Scale while study treatment is being administered. It is estimated that each study treatment will be completed in approximately 90 minutes.
Measured: During study treatment. Participants will be followed for an average of 90 minutes.
Secondary outcomes (6)
Brow lift obtained using simulines versus standard transducers
Brow lift as assessed by quantitative measurements of pre- to post-treatment photos.
Measured: 90 days post-treatment
Brow lift obtained using simulines versus standard transducers
Brow lift as assessed by quantitative measurements of pre- to post-treatment photos.
Measured: 180 days post-treatment
Improvement in overall lifting and tightening of skin
As assessed by a masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
Measured: 90 days post-treatment
Improvement in overall lifting and tightening of skin
As assessed by a masked, qualitative assessment of photographs at 180 days post-treatment compared to baseline.
Measured: 180 days post-treatment
Patient Satisfaction
As assessed by a patient satisfaction questionnaire completed by the subject.
Measured: 90 days post-treatment
Efficiency of simulines versus standard transducers
As determined by comparing treatment times using the simulines transducers compared to treatment times using the standard transducers.
Measured: During study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start15 Dec 2014
- Primary completion23 Sep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416076
- Sponsor's protocol ID
- ULT-141
- Status last verified
- Feb 2016
- First submitted
- 26 Feb 2015
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Using Standard Transducers Versus Simulines Transducers
- ClinicalTrials.gov ID
- NCT02416076
- Acronym / sponsor ID
- ULT-141
- Conditions
- Skin Laxity
- Keywords
- Ulthera® System, Ultherapy®, Ulthera, Inc.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 23 Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Apr 2015 (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 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Detailed description
This is a prospective, multi-center, split-face, randomized pilot trial to determine the clinical feasibility of the Ulthera System prototype simulines transducers, that is, transducers which deliver two lines of treatment simultaneously (at once), in comparison to the standard transducers which deliver a single treatment line, by collecting average pain scores in the treated regions, as well as efficacy and treatment efficiency data. There will be 3 study arms with each arm having 2 treatment groups. Enrolled participants will be randomized to one of two study arms, and one of two treatment groups within each study arm.to determine which side of the face will be treated with Ulthera System standard transducers and Ulthera System prototype simulines transducers and the energy level for treatment. Participants will receive one dual-depth treatment at 4.5 millimeter (mm) and 3.0mm depths.
Clinical feasibility will be assessed based on comfort level of standard transducers versus simulines transducers by comparing average pain scores obtained during study treatment. Efficacy will be determined based on qualitative masked assessment of post-treatment photographs compared to pre-treatment photographs and quantitative eyebrow lift measurements. Patient satisfaction questionnaires will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A - LT side simulines Ulthera treatment at EL2 | Active comparator | Device: Ulthera Treatment at EL2Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at the default Energy Level [EL2]. |
| Group B - RT side simulines Ulthera treatment at EL2 | Active comparator | Device: Ulthera Treatment at EL2Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFT side of the face at the default Energy Level [EL2] . |
| Group C - LT side simulines Ulthera treatment at EL4 | Active comparator | Device: Ulthera Treatment at EL4Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at a higher Energy Level [EL4]. |
| Group D - RT side simulines Ulthera treatment at EL4 | Active comparator | Device: Ulthera Treatment at EL4Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFT side of the face at a higher Energy Level [EL4] . |
| Group E - LT side simulines/standard Ulthera treatment at EL4 | Active comparator | Device: Ulthera Treatment at EL4Ulthera treatment using a 4-4.5 'Ulthera System, prototype simulines transducers' and 7-3.0 'Ulthera System, standard transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at a higher Energy Level [EL4]. |
| Group F - RT side simulines/standard Ulthera treatment at EL4 | Active comparator | Device: Ulthera Treatment at EL4Ulthera treatment using a 4-4.5 'Ulthera System, prototype simulines transducers'and 7-3.0 standard transducer on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFTof the face at a higher Energy Level [EL4]. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, age 30 to 65 years.
- Participant in good health.
- Skin laxity on the area(s) to be treated.
- 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.
Key exclusion criteria (33 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- 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.
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 Treatment at EL2Also: UltherapyFocused ultrasound energy delivered below the surface of the skin. | Device | Group A - LT side simulines Ulthera treatment at EL2, Group B - RT side simulines Ulthera treatment at EL2 |
| Ulthera Treatment at EL4Also: UltherapyFocused ultrasound energy delivered below the surface of the skin. | Device | Group C - LT side simulines Ulthera treatment at EL4, Group D - RT side simulines Ulthera treatment at EL4, Group E - LT side simulines/standard Ulthera treatment at EL4, Group F - RT side simulines/standard Ulthera treatment at EL4 |
Primary outcome
Comfort level of standard transducers versus simulines transducers during Ultherapy® treatment
Time frame: During study treatment. Participants will be followed for an average of 90 minutes.
Subjects' treatment-related pain scores will be obtained using a validated 0-10 point Numeric Rating Scale while study treatment is being administered. It is estimated that each study treatment will be completed in approximately 90 minutes.
6 secondary outcomes
Brow lift obtained using simulines versus standard transducers
Time frame: 90 days post-treatment
Brow lift obtained using simulines versus standard transducers
Time frame: 180 days post-treatment
Improvement in overall lifting and tightening of skin
Time frame: 90 days post-treatment
Improvement in overall lifting and tightening of skin
Time frame: 180 days post-treatment
Patient Satisfaction
Time frame: 90 days post-treatment
Efficiency of simulines versus standard transducers
Time frame: During study 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 23 Apr 2019.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera Treatment at EL2 and Ulthera Treatment at EL4 in people with Skin Laxity, run by Ulthera, Inc at 3 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 13 inclusion and 33 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 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Comfort level of standard transducers versus simulines transducers during Ultherapy® treatment (time frame: During study treatment. Participants will be followed for an average of 90 minutes.). 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 23 Apr 2019; AzTrials last refreshed its copy on 29 Oct 2026.