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Completed

NCT Number: NCT01368900

Reducing Wrinkles Around the Eyes Using the Ulthera® System

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.

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Key information

Conditions

Periorbital Wrinkles

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Laser Skin & Vein Institute, Hunt Valley, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ulthera® System treatment

Device

Focused ultrasound energy delivered below the surface of the skin.

Other names: Ultherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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:

    • = Very Much Improved
    • = Much Improved
    • = Improved
    • = No Change
    • = Worse

    "Any Improvement" includes subjects assessed in categories 1-3.

  2. 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:

    • = Very Much Improved
    • = Much Improved
    • = Improved
    • = No Change
    • = Worse

    "Any Improvement" includes subjects assessed in categories 1-3.

  3. 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:

    • = Very Much Improved
    • = Much Improved
    • = Improved
    • = No Change
    • = Worse

    "Any Improvement" includes subjects assessed in categories 1-3.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 8, 2011
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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