Evaluation of the Ulthera System for the Treatment of the Decolletage

Ulthera

Status

Completed

Conditions

Chest Wrinkles

Treatments

Device: Ulthera System Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01713686

ULT-129

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

Female

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.