Reducing Wrinkles Around the Eyes Using the Ulthera® System

November 16, 2017 updated by: Ulthera, Inc

Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • MD Laser Skin & Vein Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Nashville Centre for Laser and Facial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ulthera System Treatment
Ulthera treatment to the upper face.
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ultherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
Time Frame: 90 days post-treatment
Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
90 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment
Time Frame: 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.

60 days post-treatment
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment
Time Frame: 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.

90 days post-treatment
Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment
Time Frame: 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.

180 days post-treatment
Patient Satisfaction Questionnaire 90 Days Post-treatment
Time Frame: 90 days post-treatment
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.
90 days post-treatment
Patient Satisfaction Questionnaire at 180 Days Post-treatment
Time Frame: 180 days post-treatment
Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.
180 days post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Assessment of Pain
Time Frame: Average pain scores reported during study treatment
Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.
Average pain scores reported during study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Robert Weiss, M.D., MD Laser Skin & Vein Institute
  • Principal Investigator: Brian Biesman, M.D., The Nashville Centre for Laser and Facial Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (ESTIMATE)

June 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

September 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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