NCT03545412: ULT-215

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

Completed NA Results posted Last updated 12 December 2018

What this trial tests

NA trial testing Microfocused ultrasound with visualization in Facial Skin Laxity in 25 participants. Completed in 20 August 2014.

Timeline

10 January 2014

Primary endpoint
20 May 2014

20 August 2014

Quick facts

Lead sponsor	Ulthera, Inc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	10 January 2014
Primary completion	20 May 2014
Estimated completion	20 August 2014

Drugs / interventions tested

• Microfocused ultrasound with visualization

Conditions studied

• Facial Skin Laxity — all drugs for Facial Skin Laxity →

Sponsor

Ulthera, Inc — full company profile →

Who can join

Adults 39 to 65, any sex, with Facial Skin Laxity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90 Primary · 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.

Group	Value	95% CI
Ultherapy Treatment	8

Number of Participants With Lift in Brow Region at Day 90 Primary · 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.

Group	Value	95% CI
Ultherapy Treatment	12

Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90 Secondary · 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.

Group	Value	95% CI
Ultherapy Treatment	21

Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 Secondary · 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.

Group	Value	95% CI
Ultherapy Treatment	21

Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90 Secondary · Day 90

Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.

Group	Value	95% CI
Ultherapy Treatment	21

Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180 Secondary · 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.

Group	Value	95% CI
Ultherapy Treatment	22

Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180 Secondary · 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.

Group	Value	95% CI
Ultherapy Treatment	20

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Day 180. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ultherapy Treatment

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (5 terms — click to expand)

Reaction	System	Ultherapy Treatment
Contusion	Injury, poisoning and procedural complications	—
Application site edema	General disorders	—
Application site tenderness	General disorders	—
Hypersensitivity	Immune system disorders	—
Application site burn	General disorders	—

Data from ClinicalTrials.gov NCT03545412 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.