Evaluation of the Ulthera System for the Treatment of the Decolletage

Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage

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.

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.