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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01485107
First received: December 1, 2011
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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 Intervention
Skin Laxity of the décolleté
Device: Ulthera® System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in overall lifting and tightening of skin [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    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:
  • Skin Laxity of the Décolleté [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    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.

  • Bilateral chest measurements [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.

  • Overall aesthetic improvement [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    Based on Global Aesthetic Improvement Scale (GAIS) scores.

  • Patient satisfaction [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]
    Subject-completed questionnaire.


Enrollment: 24
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders 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
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: 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

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01485107     History of Changes
Other Study ID Numbers: ULT-105
Study First Received: December 1, 2011
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

ClinicalTrials.gov processed this record on October 01, 2014