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

Study Description

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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

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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

Arms and Interventions

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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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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
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