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Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02416076
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Skin Laxity Device: Ulthera Treatment at EL2 Device: Ulthera Treatment at EL4 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Using Standard Transducers Versus Simulines Transducers
Actual Study Start Date : December 15, 2014
Actual Primary Completion Date : September 23, 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A - LT side simulines Ulthera treatment at EL2
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].
Device: Ulthera Treatment at EL2
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy

Active Comparator: Group B - RT side simulines Ulthera treatment at EL2
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] .
Device: Ulthera Treatment at EL2
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy

Active Comparator: Group C - LT side simulines Ulthera treatment at EL4
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].
Device: Ulthera Treatment at EL4
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy

Active Comparator: Group D - RT side simulines Ulthera treatment at EL4
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] .
Device: Ulthera Treatment at EL4
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy

Active Comparator: Group E - LT side simulines/standard Ulthera treatment at EL4
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].
Device: Ulthera Treatment at EL4
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy

Active Comparator: Group F - RT side simulines/standard Ulthera treatment at EL4
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].
Device: Ulthera Treatment at EL4
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Brow lift obtained using simulines versus standard transducers [ Time Frame: 90 days post-treatment ]
    Brow lift as assessed by quantitative measurements of pre- to post-treatment photos.

  2. Brow lift obtained using simulines versus standard transducers [ Time Frame: 180 days post-treatment ]
    Brow lift as assessed by quantitative measurements of pre- to post-treatment photos.

  3. Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post-treatment ]
    As assessed by a masked, qualitative assessment of photographs at 90 days post‐treatment compared to baseline.

  4. Improvement in overall lifting and tightening of skin [ Time Frame: 180 days post-treatment ]
    As assessed by a masked, qualitative assessment of photographs at 180 days post‐treatment compared to baseline.

  5. Patient Satisfaction [ Time Frame: 90 days post-treatment ]
    As assessed by a patient satisfaction questionnaire completed by the subject.

  6. Efficiency of simulines versus standard transducers [ Time Frame: During study treatment ]
    As determined by comparing treatment times using the simulines transducers compared to treatment times using the standard transducers.



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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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:

    1. Postmenopausal for at least 12 months prior to study;
    2. Without a uterus and/or both ovaries; or
    3. 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. Skin tightening procedure within the past year;
    2. 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)

iii. 24 months for Poly‐L‐Lactic acid fillers (example Sculptra)

iv. Ever for permanent fillers (example Silicone, ArteFill)

c. 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:

    1. Accutane or other systemic retinoids within the past six months;
    2. Topical Retinoids within the past two weeks;
    3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
    4. Psychiatric drugs that in the investigators opinion would impair the participant 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): NCT02416076


Locations
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United States, California
Clinical Testing of Beverly Hills
Beverly Hills, California, United States, 90210
California Skin Institute - Saratoga
Saratoga, California, United States, 95070
United States, North Carolina
Wilmington Dermatology Center
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Ulthera, Inc
Investigators
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Study Director: Merz Medical Expert Merz North America, Inc.
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Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT02416076    
Other Study ID Numbers: ULT-141
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System
Ultherapy®
Ulthera, Inc.
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases