Evaluation of the Ulthera System for the Treatment of the Decolletage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01713686
First received: October 22, 2012
Last updated: March 2, 2015
Last verified: March 2015
  Purpose

This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.


Condition Intervention
Chest Wrinkles
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment [ Time Frame: 90 Days post-treatment ] [ Designated as safety issue: No ]

    Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.

    "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo.

    "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.


  • Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment [ Time Frame: 180 days post treatment ] [ Designated as safety issue: No ]

    Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.

    "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo.

    "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.



Secondary Outcome Measures:
  • Overall Aesthetic Improvement at 90 Days Post-treatment [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]

    The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:

    1. Very much improved
    2. Much improved
    3. Improved
    4. No change
    5. Worse

    The scale was completed in two steps:

    • Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and
    • Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.

    "Improved" = Very Much Improved + Much Improved + Improved


  • Overall Aesthetic Improvement at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]

    The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:

    1. Very much improved
    2. Much improved
    3. Improved
    4. No change
    5. Worse

    The scale was completed in two steps:

    • Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and
    • Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.

    "Improved" = Very Much Improved + Much Improved + Improved


  • Subject Satisfaction at 90 Days Post-treatment [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]

    Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:

    1. Very Satisfied
    2. Satisfied
    3. Neither Satisfied or Dissatisfied
    4. Dissatisfied
    5. Very Dissatisfied

    "Satisfied"= Very Satisfied + Satisfied

    "Dissatisfied"=Dissatisfied + Very Dissatisfied


  • Subject Satisfaction at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]

    Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:

    1. Very Satisfied
    2. Satisfied
    3. Neither Satisfied or Dissatisfied
    4. Dissatisfied
    5. Very Dissatisfied

    "Satisfied" = Very Satisfied + Satisfied

    "Dissatisfied" = Dissatisfied + Very Dissatisfied



Enrollment: 129
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulthera System Treatment
A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female, aged 35 to 70 years.
  • Subject in good health.
  • Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale.
  • 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.
  • Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating.
  • Absence of physical conditions unacceptable to the investigator.
  • Willingness and ability to provide written consent for study-required photography.
  • Willingness and ability to provide written informed consent.

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Scarring in areas to be treated.
  • Tattoos in the areas to be treated.
  • Patients with ports or defibrillators.
  • Any open wounds or lesions in the area.
  • Active and severe inflammatory acne in the region to be treated.
  • Patients who have a history with keloid formation or hypertrophic scarring.
  • Inability to understand the protocol or to give informed consent.
  • Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
  • Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
  • History of chronic drug or alcohol abuse.
  • History of autoimmune disease.
  • Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
  • Subjects who anticipate the need for surgery or overnight hospitalization during the study.
  • Subjects who 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 one year.
  • History of using the following prescription medications:

    1. Topical Retinoids to the area within the past two weeks;
    2. Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
    3. Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713686

Locations
United States, California
Laser Skin and Surgery Center of Northern California
Sacremento, California, United States, 95816
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, United States, 92121
United States, Illinois
Denova Research
Chicago, Illinois, United States, 60611
United States, Tennessee
Tennessee Research Center
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Mitchel P Goldman, MD Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713686     History of Changes
Other Study ID Numbers: ULT-129
Study First Received: October 22, 2012
Results First Received: January 20, 2015
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Micro-focused Ultrasound with Visualization (MFU-V)

ClinicalTrials.gov processed this record on March 26, 2015