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

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ClinicalTrials.gov Identifier: NCT03545412
Recruitment Status : Completed
First Posted : June 4, 2018
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 4, 2018
Results First Submitted Date  ICMJE November 20, 2018
Results First Posted Date  ICMJE December 12, 2018
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE January 10, 2014
Actual Primary Completion Date May 20, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
Improvement in skin laxity as measured by quantitative analysis of a minimum 20mm2 lift in submental region and neck and/or a minimum 0.5mm lift in brow region [ Time Frame: Baseline to day 90 ]
Lift improvement was considered ≥ 20.0 mm2 of the submental area Day 90 photograph compared to baseline photograph
Change History Complete list of historical versions of study NCT03545412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • 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.
  • 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.
  • 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'.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • Overall aesthetic improvement at day 90 post treatment compared to baseline, as assessed by the principal Investigator using the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Day 90 ]
    The Investigator-GAIS is a 5-point scale ranging from 5 (worse) to 1 (very much improved).
  • Overall aesthetic improvement at day 90 post treatment compared to baseline, as assessed by the subject using the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Day 90 ]
    The Subject-GAIS is a 5-point scale ranging from 5 (worse) to 1 (very much improved)
  • Patient satisfaction at the 90-day follow-up visit [ Time Frame: Day 90 ]
    Subjects completed a patient satisfaction questionnaire (PSQ) at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.
  • Overall aesthetic improvement at days 180 post treatment compared to baseline, as assessed by the principal Investigator using the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Day 180 ]
    The Investigator-GAIS is a 5-point scale ranging from 5 (worse) to 1 (very much improved).
  • Overall aesthetic improvement at days 180 post treatment compared to baseline, as assessed by the subject using the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: DAy 180 ]
    The Subject-GAIS is a 5-point scale ranging from 5 (worse) to 1 (very much improved)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
Official Title  ICMJE Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity
Brief Summary To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Facial Skin Laxity
Intervention  ICMJE Device: Microfocused ultrasound with visualization
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 Name: Ultherapy
Study Arms  ICMJE Experimental: Microfocused ultrasound with visualization
Intervention: Device: Microfocused ultrasound with visualization
Publications * Lu PH, Yang CH, Chang YC. Quantitative Analysis of Face and Neck Skin Tightening by Microfocused Ultrasound With Visualization in Asians. Dermatol Surg. 2017 Nov;43(11):1332-1338. doi: 10.1097/DSS.0000000000001181.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 20, 2014
Actual Primary Completion Date May 20, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Open wounds or lesions in the area(s) to be treated.
  2. Severe or cystic acne on the area(s) to be treated.
  3. Presence of an active systemic or local skin disease that may affect wound healing.
  4. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
  5. Subcutaneous fillers
  6. Keloid scar
  7. Patients with anticoagulant treatment plan.
  8. Children, pregnant women, breastfeeding women.
  9. 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 39 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03545412
Other Study ID Numbers  ICMJE ULT-215
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merz North America, Inc. ( Ulthera, Inc )
Study Sponsor  ICMJE Ulthera, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Merz Medical Expert Merz North America, Inc.
PRS Account Merz North America, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP