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

April 16, 2019 updated by: Ulthera, Inc

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Beverly Hills, California, United States, 90210
        • Clinical Testing of Beverly Hills
      • Saratoga, California, United States, 95070
        • California Skin Institute - Saratoga
    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • Wilmington Dermatology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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].
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • 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] .
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • 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].
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • 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] .
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • 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].
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • 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].
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ultherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During study treatment. Participants will be followed for an average of 90 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days post-treatment
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.
180 days post-treatment
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.
90 days post-treatment
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.
180 days post-treatment
Patient Satisfaction
Time Frame: 90 days post-treatment
As assessed by a patient satisfaction questionnaire completed by the subject.
90 days post-treatment
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.
During study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2014

Primary Completion (Actual)

September 23, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

February 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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