Back to resultsClinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215) (ULT-215)
Primary Purpose
Facial Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microfocused ultrasound with visualization
Sponsored by
About this trial
This is an interventional treatment trial for Facial Skin Laxity
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microfocused ultrasound with visualization
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at 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
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 Outcome Measures
Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at 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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03545412
Brief Title
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
Acronym
ULT-215
Official Title
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2014 (Actual)
Primary Completion Date
May 20, 2014 (Actual)
Study Completion Date
August 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microfocused ultrasound with visualization
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Microfocused ultrasound with visualization
Other Intervention Name(s)
Ultherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90
Description
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.
Time Frame
Baseline, Day 90
Title
Number of Participants With Lift in Brow Region at Day 90
Description
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.
Time Frame
Baseline, Day 90
Secondary Outcome Measure Information:
Title
Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90
Description
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.
Time Frame
Baseline, Day 90
Title
Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90
Description
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.
Time Frame
Baseline, Day 90
Title
Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90
Description
Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.
Time Frame
Day 90
Title
Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180
Description
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.
Time Frame
Baseline, Day 180
Title
Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180
Description
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.
Time Frame
Baseline, Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz North America, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28945618
Citation
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.
Results Reference
result
Learn more about this trial
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
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