Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

Ulthera

Status

Completed

Conditions

Facial Skin Laxity

Treatments

Device: Microfocused ultrasound with visualization

Study type

Interventional

Funder types

Industry

Identifiers

ULT-215

Details and patient eligibility

About

To evaluate the effect of the Ulthera® system for facial laxity and sagging skin

Enrollment

25 patients

Sex

All

Ages

39 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing to sign a written consent form
Willing to have of facial skin laxity and wrinkles assessed by clinician
Male or female, aged 39 to 65 years.
Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion criteria

Open wounds or lesions in the area(s) to be treated.
Severe or cystic acne on the area(s) to be treated.
Presence of an active systemic or local skin disease that may affect wound healing.
Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
Subcutaneous fillers
Keloid scar
Patients with anticoagulant treatment plan.
Children, pregnant women, breastfeeding women.
Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)