An interventional study of Microfocused ultrasound with visualization in Facial Skin Laxity, sponsored by Ulthera, Inc. Completed. Open to participants aged 39 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by Ulthera, Inc · Not applicable, Interventional, and Treatment
To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.
This study's enrollment of 25 is below the median of 30 across 129 interventional studies indexed under Cutis Laxa.
Browse Cutis Laxa studies →Ulthera, Inc is the lead sponsor of 46 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: Ultherapy
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
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
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.
Time frame: Baseline, Day 90
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.
Time frame: Baseline, Day 90
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
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.
Time frame: Baseline, Day 180
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.
Time frame: Baseline, Day 180
The study was conducted at 1 site in Taiwan.
| Milestone | Ultherapy Treatment |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
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.
| Participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90 | 8 |
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.
| Participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Lift in Brow Region at Day 90 | 12 |
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.
| Participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90 | 21 |
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.
| Participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 | 21 |
Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.
| Participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90 | 21 |
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.
| Participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180 | 22 |
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.
| Participants | Ultherapy Treatment |
|---|---|
| Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180 | 20 |
Collected over Baseline up to Day 180. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultherapy Treatment | 0/25 (0%) | 0/25 (0%) | 19/25 (76%) |
| Event | Ultherapy Treatment |
|---|---|
| ContusionInjury, poisoning and procedural complications | 17/25 |
| Application site edemaGeneral disorders | 3/25 |
| Application site tendernessGeneral disorders | 3/25 |
| HypersensitivityImmune system disorders | 1/25 |
| Application site burnGeneral disorders | 1/25 |
Baseline analysis population included all participants that were enrolled and treated with Ultherapy.
| Age, Categorical(Participants) | Ultherapy Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Ultherapy Treatment |
|---|---|
| Female | 23 |
| Male | 2 |
| Race/Ethnicity, Customized(Participants) | Ultherapy Treatment |
|---|---|
| Caucasian | 0 |
| African American/ Black | 0 |
| Hispanic/ Latino | 0 |
| Asian | 25 |
| Native Amer. Indian/ Alaskan Native | 0 |
| Region of Enrollment(participants) | Ultherapy Treatment |
|---|---|
| Taiwan | 25 |
| Body Mass Index (BMI)(kilogram per square meter (kg/m^2)) | Ultherapy Treatment |
|---|---|
| Mean | 22.0 (18.6 to 26.0) |
| Fitzpatrick Skin Type(Participants) | Ultherapy Treatment |
|---|---|
| Skin Type I | 0 |
| Skin Type II | 0 |
| Skin Type III | 3 |
| Skin Type IV | 22 |
| Skin Type V | 0 |
| Skin Type VI | 0 |
No study locations are listed for this record.
Plan to share: No
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Ulthera, Inc