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Simulines Non-Inferiority Pivotal Study

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ClinicalTrials.gov Identifier: NCT02736825
Recruitment Status : Terminated (The study data to date show the required primary study endpoint will not be met.)
First Posted : April 13, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Brief 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. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.

Condition or disease Intervention/treatment Phase
Skin Laxity Device: Ultherapy® Device: Standard transducer Device: Simulines transducer Not Applicable

Detailed Description:

This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate that the safety and efficacy of a new transducer which delivers two simultaneous lines of treatment at the same treatment depth is not inferior to a standard transducer to improve jawline definition and submental skin laxity.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 4, 2016
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A, Ultherapy® using Standard transducers

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 Energy Level (EL)2:

  • 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
Device: Ultherapy®
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ulthera® System

Device: Standard transducer
Commercially available transducer designed to deliver focused ultrasound energy below the surface of the skin, delivering one line of treatment at a time.

Experimental: Group B, Ultherapy® using Simulines transducers

Subjects randomized to Group B will receive a comparable treatment with a total minimum pulse count of 336 pulses (+5%) using the 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
Device: Ultherapy®
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ulthera® System

Device: Simulines transducer
New transducer designed to deliver focused ultrasound energy below the surface of the skin, delivering two lines of treatment simultaneously.




Primary Outcome Measures :
  1. Quantitative measurements of neck and submental lift [ Time Frame: 90 days post treatment ]
    Subject response as assessed by methodology and success criteria used to support the FDA clearance of the submental/neck lift indication for Ultherapy®. Response is defined as ≥20 mm2 reduction in 2D submental area from baseline.


Secondary Outcome Measures :
  1. Quantitative measurements of neck and submental lift [ Time Frame: 180 days post treatment ]
    Subject response as assessed by methodology and success criteria used to support the FDA clearance of the submental/neck lift indication for Ultherapy®. Response is defined as ≥20 mm2 reduction in 2D submental area from baseline.

  2. Quantitative measurements of neck and submental lift [ Time Frame: 365 days post treatment ]
    Subject response as assessed by methodology and success criteria used to support the FDA clearance of the submental/neck lift indication for Ultherapy®. Response is defined as ≥20 mm2 reduction in 2D submental area from baseline.

  3. Overall lifting and tightening of skin [ Time Frame: 90 days post treatment ]
    As determined by a masked, qualitative assessment of post treatment photographs compared to baseline.

  4. Overall lifting and tightening of skin [ Time Frame: 180 days post treatment ]
    As determined by a masked, qualitative assessment of post treatment photographs compared to baseline.

  5. Overall lifting and tightening of skin [ Time Frame: 365 days post treatment ]
    As determined by a masked, qualitative assessment of post treatment photographs compared to baseline.

  6. Mean change from baseline to post treatment on the validated Merz Jawline Grading Scale (MJGS) [ Time Frame: 90 days post treatment ]
    As assessed by independent masked evaluators comparing baseline study photographs to post treatment study photographs.

  7. Volumetric changes from baseline [ Time Frame: 90 days ]
    As determined by comparing 3D imaging at baseline to post treatment.

  8. Volumetric changes from baseline [ Time Frame: 180 days ]
    As determined by comparing 3D imaging at baseline to post treatment.

  9. Volumetric changes from baseline [ Time Frame: 365 days ]
    As determined by comparing 3D imaging at baseline to post treatment.

  10. Treatment times using Simulines versus Standard transducers [ Time Frame: During study treatment (Day 0 post treatment) ]
    Based on a comparison of average time to complete treatment using each transducer type.

  11. Subjects' treatment-related comfort level [ Time Frame: During study treatment (Day 0 post treatment) ]
    Based on a comparison of average pain scores using a validated Numeric Rating Scale using each transducer type.

  12. 90-day Subject Global Aesthetic Improvement (SGAIS) Scale [ Time Frame: 90 days post treatment ]

    SGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse

  13. 180-day Subject Global Aesthetic Improvement (SGAIS) Scale [ Time Frame: 180 days post treatment ]

    SGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse

  14. 365-day Subject Global Aesthetic Improvement (SGAIS) Scale [ Time Frame: 365 days post treatment ]

    SGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse

  15. 90-day Clinician Global Aesthetic Improvement (CGAIS) Scale [ Time Frame: 90 days post treatment ]

    CGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse

  16. 180-day Clinician Global Aesthetic Improvement (CGAIS) Scale [ Time Frame: 180 days post treatment ]

    CGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse

  17. 365-day Clinician Global Aesthetic Improvement (CGAIS) Scale [ Time Frame: 365 days post treatment ]

    CGAIS assessing overall aesthetic improvement based on a 5-point scale, rating improvement from the pre-treatment appearance:

    • 1=very much improved
    • 2=much improved
    • 3=improved
    • 4=no change
    • 5=worse

  18. Patient Satisfaction and Patient-Reported Improvement [ Time Frame: 90 days post treatment ]
    Based on data collected via a Patient Satisfaction Questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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:

    a. 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. Any energy based device (radio-frequency (RF), micro-focused ultrasound (MFU), etc.) procedure for skin tightening within the past year;
    2. Injectable filler of any type within the past:

    i. 12 months for Hyaluronic acid fillers (e.g. Restylane)

ii. 12 months for Ca Hydroxylapatite fillers (e.g. Radiesse)

iii. 24 months for Long Lasting Hyaluronic acid (e.g. Voluma) and Poly-L-Lactic acid fillers (e.g. Sculptra)

iv. Ever for permanent fillers (e.g. Silicone, ArteFill)

c. 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);

d. Fractional and fully ablative resurfacing laser treatment within the past two years;

e. Nonablative, rejuvenative laser or light treatment within the past six months;

f. Surgical dermabrasion or deep facial peels within the past two years;

g. Facelifts, neck surgery (e.g. thyroid, neck lifts, neck liposuction, etc.) within the past two years;

h. Micro needling within the past year;

i. Kybella, Coolsculpting, or Mesotherapy within the past two years; or

j. Any history of contour threads.

  • History (in the prior year) or current use of the following prescription medications:

    1. Accutane or other systemic retinoids within the past six months;
    2. Initiation of topical retinoids within the past 6 months or throughout the course of the study;
    3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
    4. Systemic steroids including prednisone;
    5. Dermal regulators of collagen;
    6. Initiation of bioidentical hormones or human growth hormone (HGH) within the past 6 months or throughout the course of the study; or
    7. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736825


Locations
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United States, California
Clinical Testing of Beverly Hills
Beverly Hills, California, United States, 90210
Roseville Facial Plastic Surgery
Roseville, California, United States, 95661
Laser and Skin Surgery Center
Sacramento, California, United States, 95816
Dermatology Cosmetic Laser Medical Associates of La Jolla
San Diego, California, United States, 92121
United States, Colorado
AboutSkin Dermatology
Greenwood Village, Colorado, United States, 80111
United States, Maryland
Maryland Laser Skin and Vein Dermatology
Cockeysville, Maryland, United States, 21030
United States, North Carolina
Wilmington Dermatology Center
Wilmington, North Carolina, United States, 28403
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 92202
Sponsors and Collaborators
Ulthera, Inc
Investigators
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Study Director: Kari Larson, MBA Ulthera, Inc

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Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT02736825     History of Changes
Other Study ID Numbers: ULT-146
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases