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Completed

NCT Number: NCT01519206

Lifting and Tightening of the Face and Neck Following an Increased Density Treatment

The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser & Skin Surgery Center of NY

New York, 10016, United States

About this study

All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.

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
  • Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion criteria

  • Presence of an active systemic or local skin disease that may affect wound healing
  • Severe solar elastosis
  • Excessive subcutaneous fat on the cheeks
  • Excessive skin laxity on the lower face and neck
  • 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, a pacemaker, or cochlear implants

Treatment and study plan

Ulthera System Treatment

Device

Focused ultrasound energy delivered below the surface of the skin.

Other names: Ultherapy™, Ulthera, Inc., Ultrasound treatment for skin tightening

Primary outcomes

  1. Improvement in Overall Lifting and Tightening of Skin

    Time frame: Baseline to 90 days post treatment

    Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.

Secondary outcomes

  1. Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.

    Time frame: Baseline to 60 days, 90 days, 180 days and 1 year post-treatment

    Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

    • - Very Much Improved
    • - Much Improved
    • - Improved
    • - No Change
    • - Worse

  2. Subjects' Assessment of Pain

    Time frame: During Ulthera treatment

    Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.

  3. Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment

    Time frame: Baseline to 90 days, 180 days and 1 year post-treatment

    Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 26, 2012
Registry last updated
Dec 11, 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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