Reducing Wrinkles Around the Eyes Using the Ulthera® System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01368900
First received: June 6, 2011
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Periorbital Wrinkles
Device: Ulthera® System treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.


Secondary Outcome Measures:
  • Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment [ Time Frame: 60 days post-treatment ] [ Designated as safety issue: No ]

    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.


  • Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]

    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.


  • Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]

    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.


  • Patient Satisfaction Questionnaire 90 Days Post-treatment [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.

  • Patient Satisfaction Questionnaire at 180 Days Post-treatment [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.


Other Outcome Measures:
  • Subject Assessment of Pain [ Time Frame: Average pain scores reported during study treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 68
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulthera System Treatment
Ulthera treatment to the upper face.
Device: Ulthera® System treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368900

Locations
United States, Maryland
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, Tennessee
The Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Ulthera, Inc
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
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01368900     History of Changes
Other Study ID Numbers: ULT-111
Study First Received: June 6, 2011
Results First Received: April 17, 2013
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

ClinicalTrials.gov processed this record on August 18, 2014