Skin LaxityNCT02736825
Simulines Non-Inferiority Pivotal Study
A study testing Ulthera System with standard transducer and Ulthera System with prototype 2 simulines transducer in people with Skin Laxity, run by Ulthera, Inc at 8 sites in United States.
Trial summary
Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Ulthera System with standard transducer and Ulthera System with prototype 2 simulines transducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Apr 2016to 25 Apr 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 30 to 70 years.
- Subject in good health.
- Body Mass Index (BMI) of ≤30.
- Skin laxity in the area(s) to be treated as determined by trained physician assessors.
- Willingness to avoid excessive or prolonged exposure to sunlight, tanning booths, sun lamps, or ultraviolet (UV) light sources.
- Willingness to apply study provided sunscreen (Neocutis Micro-Day Rejuvenating Cream) daily until study exit to help limit sun exposure.
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- Willingness to avoid or periodically stop use of Sunless Tanners (washout period of two weeks prior to each study visit is required).
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
- Willingness to avoid non-emergent dental procedures in the 3 weeks prior to/ post treatment.
- 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.
- 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, 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:
- Postmenopausal for at least 12 months prior to study; b. Without a uterus and/or both ovaries; or c. 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 non-steroidal anti-inflammatory drug (NSAID) prior to study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the study treatment. After study treatment is completed, limited acute NSAID use, i.e., a maximum of 2-3 doses in any 2 week period, is allowed if needed.
- 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 and 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.
- History of Bell's Palsy.
- History of chronic or frequently recurring episodic (recurrent episode in past 12 months) autoimmune diseases such as Multiple Sclerosis, Crohn's Disease, Psoriasis, Myasthenia Gravis, Lambert-Eaton Syndrome that has required immune suppressant therapy (such as biologic drug or corticosteroid treatment).
- Palpable thyroid lesion, lymphadenopathy, or other pathological changes within the treatment area.
- History of skin cancer in the areas to be treated, basal cell nevus syndrome, or jaw cysts.
- Known allergy or sensitivity to Ibuprofen.
Show all 49Show fewer
- Severe solar elastosis.
- BMI > 30.
- Significant changes in weight (e.g. more than 5 pounds) over the past 6 months or anticipated significant changes in weight or diet over the course of the study.
- Pregnant within the past year.
- Excessive subcutaneous fat in the area(s) to be treated.
- Excessive skin laxity in the area(s) to be treated as determined by trained physician assessors.
- Significant scarring in the area(s) to be treated that would interfere with assessing results.
- 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.
- 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.
- History of chronic drug or alcohol abuse.
- 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 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 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, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- History of the following cosmetic treatments in the area(s) to be treated:
- Any energy based device (radio-frequency (RF), micro-focused ultrasound (MFU), etc.) procedure for skin tightening within the past year;
- Injectable filler of any type within the past:
- 12 months for Hyaluronic acid fillers (e.g. Restylane)
- 12 months for Ca Hydroxylapatite fillers (e.g. Radiesse)
- 24 months for Long Lasting Hyaluronic acid (e.g. Voluma) and Poly-L-Lactic acid fillers (e.g. Sculptra)
- Ever for permanent fillers (e.g. Silicone, ArteFill)
- Neurotoxins within the past six months (neuromodulators are allowed in the glabella and forehead, not allowed in the temples, crow's fee or anywhere below the lateral canthus);
- Fractional and fully ablative resurfacing laser treatment within the past two years;
- Nonablative, rejuvenative laser or light treatment within the past six months;
- Surgical dermabrasion or deep facial peels within the past two years;
- Facelifts, neck surgery (e.g. thyroid, neck lifts, neck liposuction, etc.) within the past two years;
- Micro needling within the past year;
- Kybella, Coolsculpting, or Mesotherapy within the past two years; 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;
- Initiation of topical retinoids within the past 6 months or throughout the course of the study;
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
- Systemic steroids including prednisone;
- Dermal regulators of collagen;
- Initiation of bioidentical hormones or human growth hormone (HGH) within the past 6 months or throughout the course of the study; or
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Clinical Testing of Beverly Hills
Beverly Hills, California, 90210
Maryland Laser Skin and Vein Dermatology
Cockeysville, Maryland, 21030
AboutSkin Dermatology
Greenwood Village, Colorado, 80111
Roseville Facial Plastic Surgery
Roseville, California, 95661
Laser and Skin Surgery Center
Sacramento, California, 95816
Dermatology Cosmetic Laser Medical Associates of La Jolla
San Diego, California, 92121
Premier Clinical Research
Spokane, Washington, 92202
Wilmington Dermatology Center
Wilmington, North Carolina, 28403
About this study
Official title: Non-Inferiority Study of the Safety and Efficacy of Ultherapy® Using Standard Versus Simulines Transducers at a Reduced Energy Level for Patient Comfort
Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.
Read the detailed description
This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate the efficacy of the Ultherapy treatment with prototype 2 simulines transducers (4-3.0 Smm and 4-4.5 Smm) at energy level (EL) 2 is non-inferior to treatment with standard transducers (7-3.0 mm and 4-4.5mm) at EL 2 for lifting the lower face and neck and to demonstrate the safety of treatment with prototype 2 simulines transducers is similar to treatment with standard transducers.
Changes from baseline in quantitative measures of neck and submental lift will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, Merz Jawline Grading Scale scores, 3D volumetric changes from baseline to post treatment, patient satisfaction and patient-reported improvement will be obtained.
- Conditions
- Skin Laxity
- Being tested
- Ulthera System with standard transducer, Ulthera System with prototype 2 simulines transducer
- 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 System with standard transducerDevice
Also called Ultherapy
Focused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time
Ulthera System with prototype 2 simulines transducerDevice
Also called Ultherapy
Focused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Group A, Ulthera System with standard transducers | Active comparator | Subjects randomized to Group A will receive an Ultherapy® treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5%) at the 4.5mm and 3.0mm depths using standard transducers. Energy levels for each transducer will be set to EL2:
* Deep-See (DS) 4-4.5 at 0.9 Joules (J) with pitch of 1.5mm and 17 Thermal Coagulation Points (TCP)s per line
* DS 7-3.0 at 0.30J with pitch of 1.1mm and 23 TCPs per line Receives: Device: Ulthera System with standard transducer |
| Group B, Ulthera System with prototype 2 simulines transducers | Experimental | Subjects randomized to Group B will receive a Ultherapy® treatment with a total minimum pulse count of 336 pulses (+5%) using the prototype 2 simulines transducers at the 4.5mm and 3.0mm depths. Energy levels for each transducer will be set to EL2:
* Deep-See 4-4.5 Simulines (DS 4-4.5S) at 1.23J with pitch of 1.5mm and 17 TCPs per line
* DS 4-3.0S at 0.88J with pitch of 1.3mm and 20 TCPs per line Receives: Device: Ulthera System with prototype 2 simulines transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90
Participant response was defined as >=20 mm^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Measured: Day 90
Secondary outcomes (17)
Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 180
Participant response was defined as >=20 mm^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Measured: Day 180
Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 365
Participant response was defined as >=20 mm^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
Measured: Day 365
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 90
Improvement was determined by qualitative assessment of photographs by a masked physician.
Measured: Day 90
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 180
Improvement was determined by qualitative assessment of photographs by a masked physician.
Measured: Day 180
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 365
Improvement was determined by qualitative assessment of photographs by a masked physician.
Measured: Day 365
Percent Change From Baseline in Volume as Assessed by Quantificare 3 D Imaging System at Day 90
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Measured: Day 90
Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 180
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Measured: Day 180
Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 365
Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.
Measured: Day 365
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Participants completed a patient satisfaction questionnaire (PSQ) at the 90-day visit. The PSQ has 5 improvement and satisfaction categories ranging from "worse" to "much improved" and "dissatisfied' to "very satisfied".
Measured: Day 90
Mean Treatment Times
Mean treatment time was based on a comparison of average time to complete treatment using each transducer type. The time to complete the study treatment for each group was recorded on the system treatment logs as treatment start time (time treatment started on the Ulthera system) and stop time (time treatment ended on the Ulthera system).
Measured: Baseline
Mean Pain Scores to Assess Participant's Treatment Related Comfort Level Based on Numeric Rating Scale (NRS)
Participant's treatment-related pain scores were obtained using a validated 11-point NRS with 0: no pain; 5: moderate pain; and 10: worst possible pain. Pain scores were obtained following each region treated (submandibular/submental and cheeks) and for each transducer used during treatment. Average pain score was calculated for each arm by adding all the scores of all participants in each arm to obtain the mean NRS score.
Measured: Baseline
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Measured: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Measured: Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 365
Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Measured: Day 365
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Measured: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Measured: Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 365
Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start11 Apr 2016
- Primary completion20 Jan 2017
- Study completion25 Apr 2017
Why it stopped: The study data to date show the required primary study endpoint will not be met.
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari Larson, MBA, Study director, Ulthera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736825
- Sponsor's protocol ID
- ULT-146
- Status last verified
- Jan 2018
- First submitted
- 4 Apr 2016
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Study of the Safety and Efficacy of Ultherapy® Using Standard Versus Simulines Transducers at a Reduced Energy Level for Patient Comfort
- ClinicalTrials.gov ID
- NCT02736825
- Acronym / sponsor ID
- ULT-146
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study data to date show the required primary study endpoint will not be met.
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 19 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.
Detailed description
This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate the efficacy of the Ultherapy treatment with prototype 2 simulines transducers (4-3.0 Smm and 4-4.5 Smm) at energy level (EL) 2 is non-inferior to treatment with standard transducers (7-3.0 mm and 4-4.5mm) at EL 2 for lifting the lower face and neck and to demonstrate the safety of treatment with prototype 2 simulines transducers is similar to treatment with standard transducers.
Changes from baseline in quantitative measures of neck and submental lift will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, Merz Jawline Grading Scale scores, 3D volumetric changes from baseline to post treatment, patient satisfaction and patient-reported improvement will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, Ulthera System with standard transducers | Active comparator | Device: Ulthera System with standard transducerSubjects randomized to Group A will receive an Ultherapy® treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5%) at the 4.5mm and 3.0mm depths using standard transducers. Energy levels for each transducer will be set to EL2: * Deep-See (DS) 4-4.5 at 0.9 Joules (J) with pitch of 1.5mm and 17 Thermal Coagulation Points (TCP)s per line * DS 7-3.0 at 0.30J with pitch of 1.1mm and 23 TCPs per line |
| Group B, Ulthera System with prototype 2 simulines transducers | Experimental | Device: Ulthera System with prototype 2 simulines transducerSubjects randomized to Group B will receive a Ultherapy® treatment with a total minimum pulse count of 336 pulses (+5%) using the prototype 2 simulines transducers at the 4.5mm and 3.0mm depths. Energy levels for each transducer will be set to EL2: * Deep-See 4-4.5 Simulines (DS 4-4.5S) at 1.23J with pitch of 1.5mm and 17 TCPs per line * DS 4-3.0S at 0.88J with pitch of 1.3mm and 20 TCPs per line |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female, age 30 to 70 years.
- Subject in good health.
- Body Mass Index (BMI) of ≤30.
- Skin laxity in the area(s) to be treated as determined by trained physician assessors.
- Willingness to avoid excessive or prolonged exposure to sunlight, tanning booths, sun lamps, or ultraviolet (UV) light sources.
Key exclusion criteria (49 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- History of Bell's Palsy.
- History of chronic or frequently recurring episodic (recurrent episode in past 12 months) autoimmune diseases such as Multiple Sclerosis, Crohn's Disease, Psoriasis, Myasthenia Gravis, Lambert-Eaton Syndrome that has required immune suppressant therapy (such as biologic drug or corticosteroid treatment).
- Palpable thyroid lesion, lymphadenopathy, or other pathological changes within the treatment area.
- History of skin cancer in the areas to be treated, basal cell nevus syndrome, or jaw cysts.
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 with standard transducerAlso: UltherapyFocused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time | Device | Group A, Ulthera System with standard transducers |
| Ulthera System with prototype 2 simulines transducerAlso: UltherapyFocused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously | Device | Group B, Ulthera System with prototype 2 simulines transducers |
Primary outcome
Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90
Time frame: Day 90
Participant response was defined as >=20 mm^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.
17 secondary outcomes
Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 180
Time frame: Day 180
Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 365
Time frame: Day 365
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 90
Time frame: Day 90
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 180
Time frame: Day 180
Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 365
Time frame: Day 365
Percent Change From Baseline in Volume as Assessed by Quantificare 3 D Imaging System at Day 90
Time frame: Day 90
Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 180
Time frame: Day 180
Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 365
Time frame: Day 365
Number of Participants With Some Level of Improvement and Satisfaction on Day 90
Time frame: Day 90
Mean Treatment Times
Time frame: Baseline
Mean Pain Scores to Assess Participant's Treatment Related Comfort Level Based on Numeric Rating Scale (NRS)
Time frame: Baseline
Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Time frame: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180
Time frame: Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 365
Time frame: Day 365
Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90
Time frame: Day 90
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180
Time frame: Day 180
Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 365
Time frame: Day 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kari Larson, MBA study director
Ulthera, Inc
8 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 with standard transducer and Ulthera System with prototype 2 simulines transducer in people with Skin Laxity, run by Ulthera, Inc at 8 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 16 inclusion and 49 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: stopped early, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 19 Feb 2020). 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 Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90 (time frame: Day 90). 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 19 Feb 2020.