Evaluation of the Ulthera System for the Treatment of the Decolletage

Completed · Not applicable

Conditions studied: Chest Wrinkles

In brief

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.

Key facts

Study ID

NCT01713686

Run by

Ulthera, Inc

People needed

129

Starts

2012-10-01

Expected to finish

2013-08-01

Last updated by the study team

2017-12-11

Who can join

Age: 35 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Topical Retinoids to the area within the past two weeks;
• Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
• Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Where it is running

• 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

Full record on ClinicalTrials.gov

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