Reducing Wrinkles Around the Eyes Using the Ulthera® System

Ulthera, Inc68 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periorbital Wrinkles

Interventions

Ulthera® System treatmentDEVICE

Focused ultrasound energy delivered below the surface of the skin.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

MD Laser Skin & Vein Institute

Hunt Valley, Maryland, United States

The Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes

Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.

Time frame: 90 days post-treatment

Secondary Outcomes

Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment

At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse "Any Improvement" includes subjects assessed in categories 1-3.

Time frame: 60 days post-treatment

Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment

At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse "Any Improvement" includes subjects assessed in categories 1-3.

Time frame: 90 days post-treatment

Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment

At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows: 1. = Very Much Improved 2. = Much Improved 3. = Improved 4. = No Change 5. = Worse "Any Improvement" includes subjects assessed in categories 1-3.

Time frame: 180 days post-treatment

Patient Satisfaction Questionnaire 90 Days Post-treatment

Data from ClinicalTrials.gov

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