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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03545412

Acronym

ULT-215

Enrollment

Registered

2018-06-04

Start date

2014-01-10

Completion date

2014-08-20

Last updated

2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Skin Laxity

Brief summary

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

Interventions

DEVICEMicrofocused 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

39 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90	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	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

Measure	Time frame	Description
Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90	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 Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90	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 SGAIS at Day 180	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.
Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180	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 Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90	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.

Participant flow

Recruitment details

The study was conducted at 1 site in Taiwan.

Pre-assignment details

A total of 25 participants were screened, enrolled and treated in the study.

Participants by arm

Arm	Count
Ultherapy Treatment Participants received Ultherapy treatment to the facial areas including upper neck, cheek, brow, lateral orbit and infraorbital delivering a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5 millimeter (mm) and 7-3.0 mm transducer depths.	25
Total	25

Baseline characteristics

Characteristic	Ultherapy Treatment
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	25 Participants
Body Mass Index (BMI)	22.0 kilogram per square meter (kg/m^2)
Fitzpatrick Skin Type Skin Type I	0 Participants
Fitzpatrick Skin Type Skin Type II	0 Participants
Fitzpatrick Skin Type Skin Type III	3 Participants
Fitzpatrick Skin Type Skin Type IV	22 Participants
Fitzpatrick Skin Type Skin Type V	0 Participants
Fitzpatrick Skin Type Skin Type VI	0 Participants
Race/Ethnicity, Customized African American/ Black	0 Participants
Race/Ethnicity, Customized Asian	25 Participants
Race/Ethnicity, Customized Caucasian	0 Participants
Race/Ethnicity, Customized Hispanic/ Latino	0 Participants
Race/Ethnicity, Customized Native Amer. Indian/ Alaskan Native	0 Participants
Region of Enrollment Taiwan	25 participants
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 25
other Total, other adverse events	19 / 25
serious Total, serious adverse events	0 / 25

Outcome results

Primary

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.

Time frame: Baseline, Day 90

Population: All participants enrolled and treated with Ultherapy. Only participants categorized as good candidates for photographs were included in the analysis. Good candidates for photographs was defined as those participants who had sufficient distance between the menton and neck, and enough lower face volume to allow for accurate measurements.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Ultherapy Treatment	Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90	8 Participants

Primary

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.

Time frame: Baseline, Day 90

Population: All participants who were treated with Ultherapy were included for the assessment. The analysis included all participants who had the measurement available for brows. One participant excluded due to inability to measure brow.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Ultherapy Treatment	Number of Participants With Lift in Brow Region at Day 90	12 Participants

Secondary

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'.

Time frame: Day 90