Reducing Wrinkles Around the Eyes Using the Ulthera® System

Ulthera

Status

Completed

Conditions

Periorbital Wrinkles

Treatments

Device: Ulthera® System treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01368900

ULT-111

Details and patient eligibility

About

The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.

Full description

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.

Enrollment

68 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, aged 30 to 65 years.
Subject in good health.
Mild to moderate rhytids in the periorbital region.
Willingness and ability to comply with protocol requirements and return for follow-up visits.
Not pregnant.
Provide written informed consent and HIPAA authorization.

Exclusion criteria

Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Excessive subcutaneous fat in the face.
Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
Excessive hooding, with or without redundant skin, in the areas to be treated.
Significant scarring in areas to be treated.
Significant open facial wounds or lesions.
Severe or cystic acne on the face.
Presence of a metal stent or implant in the facial area to be treated.