ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

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: NCT01485107
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

Condition or disease Intervention/treatment Phase
Skin Laxity of the décolleté Device: Ulthera® System Not Applicable

Detailed Description:
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté
Study Start Date : June 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Ultherapy™ treatment on the décolleté
All enrolled subjects will receive the study treatment.
 Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy™ treatment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post-treatment ]
    Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.


Secondary Outcome Measures :
  1. Skin Laxity of the Décolleté [ Time Frame: 90 and 180 days post-treatment ]
    The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.

  2. Bilateral chest measurements [ Time Frame: 90 and 180 days post-treatment ]
    Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.

  3. Overall aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ]
    Based on Global Aesthetic Improvement Scale (GAIS) scores.

  4. Patient satisfaction [ Time Frame: 90 and 180 days post-treatment ]
    Subject-completed questionnaire.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female, aged 35 to 60 years.
  • Subject in good health.
  • Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
  • 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.

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.
  • Breast size >400cc each as measured by water displacement method.
  • History of breast reduction surgery.
  • 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 hypertropic scarring
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01485107


Locations
United States, California
Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
San Diego, California, United States, 92121
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Michael Goldman, MD Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01485107     History of Changes
Other Study ID Numbers: ULT-105
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: June 2013

Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

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