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Completed

NCT Number: NCT01368965

Lifting and Tightening of the Face in Subjects With Skin of Darker Color

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

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Key information

Conditions

Facial Skin Laxity

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harris Aesthetics, LLC, Chevy Chase, Maryland, United States

Loading trial locations.

About this study

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

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.
  • Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
  • Fitzpatrick skin phototypes of 3 through 6.
  • Provide written informed consent and HIPAA authorization

Exclusion criteria

  • Pregnant or lactating.
  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat on the cheek.
  • 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.

Treatment and study plan

Ulthera® System treatment

Device

Ulthera® System treatment delivering focused ultrasound energy

Primary outcomes

  1. Change in Overall Lifting and Tightening of Treated Tissue

    Time frame: 90 days post treatment

    The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos

Secondary outcomes

  1. Global Aesthetic Improvement 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. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.

  2. Global Aesthetic Improvement 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. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.

  3. Patient Satisfaction Questionnaire

    Time frame: 90 Days post-treatment

    Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.

  4. Patient Satisfaction Questionnaire

    Time frame: 180 days post-treatment

    Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.

Other outcomes

  1. Subject Assessment of Pain

    Time frame: During Ulthera treatment

    Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6

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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