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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: February 27, 2013
Last verified: February 2013
History of Changes
  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: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

Resource links provided by NLM:

U.S. FDA Resources

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
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: February 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

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

ClinicalTrials.gov processed this record on May 22, 2013