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Completed

NCT Number: NCT03545412

Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

To evaluate the effect of the Ulthera® system for facial laxity and sagging skin

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Key information

Conditions

Facial Skin Laxity

Age range

39 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing to sign a written consent form
  • Willing to have of facial skin laxity and wrinkles assessed by clinician
  • Male or female, aged 39 to 65 years.
  • Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
  • Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
  • Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
  • Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion criteria

  • Open wounds or lesions in the area(s) to be treated.
  • Severe or cystic acne on the area(s) to be treated.
  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
  • Subcutaneous fillers
  • Keloid scar
  • Patients with anticoagulant treatment plan.
  • Children, pregnant women, breastfeeding women.
  • Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)

Treatment and study plan

Microfocused ultrasound with visualization

Device

Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths

Other names: Ultherapy

Primary outcomes

  1. Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90

    Time frame: Baseline, Day 90

    Lift improvement as measured by quantitative analysis was considered greater than or equal to (>=) 20.0 square millimeter (mm^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest.

  2. Number of Participants With Lift in Brow Region at Day 90

    Time frame: Baseline, Day 90

    Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area.

Secondary outcomes

  1. Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90

    Time frame: Baseline, Day 90

    Overall aesthetic improvement was assessed by the principal investigator using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each principal investigator completed a GAIS, known as physician global aesthetic improvement scale (PGAIS) .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.

  2. Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90

    Time frame: Baseline, Day 90

    Overall aesthetic improvement was assessed by participants using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each participant completed a GAIS, known as SGAIS.The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.

  3. Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90

    Time frame: Day 90

    Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.

  4. Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180

    Time frame: Baseline, Day 180

    Overall aesthetic improvement was assessed by the principal investigator using the GAIS. At 180 days post-treatment, each principal investigator completed a GAIS, known as PGAIS .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.

  5. Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180

    Time frame: Baseline, Day 180

    Overall aesthetic improvement was assessed by participants using GAIS. At 180 days post-treatment, each participant completed a GAIS, known as SGAIS. The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity

Acronym: ULT-215

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2018
Registry last updated
Dec 12, 2018

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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