Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ulthera, Inc
Age
35–70
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible 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 be 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:
1. Topical Retinoids to the area within the past two weeks;
