- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545412
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215) (ULT-215)
November 20, 2018 updated by: Ulthera, Inc
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity
To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
39 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Day 90
|
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.
|
Baseline, Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Day 90
|
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.
|
Baseline, Day 90
|
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'.
|
Day 90
|
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.
|
Baseline, Day 180
|
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.
|
Baseline, Day 180
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 10, 2014
Primary Completion (ACTUAL)
May 20, 2014
Study Completion (ACTUAL)
August 20, 2014
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
May 22, 2018
First Posted (ACTUAL)
June 4, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 12, 2018
Last Update Submitted That Met QC Criteria
November 20, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULT-215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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