Evaluation of the Ulthera System for the Treatment of the Decolletage - Full Text View

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:

Number 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

Secondary Outcome Measures:

Overall Aesthetic Improvement [ Time Frame: Participants will be followed to 180 days post-treatment ] [ Designated as safety issue: No ]
Overall aesthetic improvement at each post treatment study visit will be compared to baseline will be assessed using the Global Aesthetic Improvement Scale (GAIS).
Subject Satisfaction [ Time Frame: Participants will be followed to180 days post-treatment ] [ Designated as safety issue: No ]
Subject satisfaction will be measured at each follow-up visit using a Patient Satisfaction Questionnaire.
Number 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

Estimated Enrollment:	130
Study Start Date:	October 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ulthera System Treatment Ulthera System treatment of the decolletage	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

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
Last Updated:	February 25, 2013
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 May 22, 2013