Evaluation of the Ulthera System for the Treatment of the Decolletage

NCT ID: NCT01713686

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

Conditions

Chest Wrinkles

Keywords

Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Micro-focused Ultrasound with Visualization (MFU-V)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ulthera System Treatment

A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.

Group Type: EXPERIMENTAL

Ulthera System Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin

Interventions

Ulthera System Treatment

Focused ultrasound energy delivered below the surface of the skin

Intervention Type: DEVICE

Other Intervention Names

Ultherapy™

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ulthera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchel P Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Locations

Laser Skin and Surgery Center of Northern California

Sacramento, California, United States

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California, United States

Denova Research

Chicago, Illinois, United States

Tennessee Research Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

ULT-129

Identifier Type: -

Identifier Source: org_study_id