Trial Outcomes & Findings for Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum (NCT NCT04795622)

NCT ID: NCT04795622

Last Updated: 2023-03-23

Results Overview

Lower face and submental skin laxity were determined by three blinded evaluators after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 201 participants
• Primary outcome timeframe: Day 90
• Results posted on: 2023-03-23

Participant Flow

Subjects were recruited from 5 investigational sites in China.

Of the 213 screened subjects,12 were exited as screen failures and 201 subjects were enrolled and randomized in this study.

Participant milestones

Measure	Treatment With Ulthera DeepSEE System Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Overall Study STARTED	101	100
Overall Study Safety Evaluation Set (SES)	97	96
Overall Study COMPLETED	88	84
Overall Study NOT COMPLETED	13	16

Reasons for withdrawal

Measure	Treatment With Ulthera DeepSEE System Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	3	3
Overall Study Protocol Violation	0	2
Overall Study Lost to Follow-up	2	3
Overall Study Other	7	8

Baseline Characteristics

Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum

Baseline characteristics by cohort

Measure	Treatment With Ulthera DeepSEE System n=97 Participants Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System n=96 Participants Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.	Total n=193 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 7.57 • n=5 Participants	47.3 years STANDARD_DEVIATION 7.24 • n=7 Participants	47.1 years STANDARD_DEVIATION 7.39 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	94 Participants n=7 Participants	185 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	97 Participants n=5 Participants	96 Participants n=7 Participants	193 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 90

Population: The full analysis set (FAS) included all subjects randomized with baseline photographs of acceptable quality.

Lower face and submental skin laxity were determined by three blinded evaluators after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.

Outcome measures

Measure	Treatment With Ulthera DeepSEE System n=96 Participants Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System n=100 Participants Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Percentage of Subjects With Improvement in Lower Face and Submental Skin Laxity at Day 90	54.2 percentage of subjects	47.0 percentage of subjects

SECONDARY outcome

Timeframe: Day 90

Population: FAS. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure.

Displacement of skin (in millimeters [mm]) in the submentum was determined by three-dimensional (3D) quantitative photographic analysis by comparing Day 90 photographs with baseline photographs. X-axis (lateral), Y-axis (vertical), and Z-axis (anterior to posterior) direction components were provided for both sides of the face combined (that is, overall).

Outcome measures

Measure	Treatment With Ulthera DeepSEE System n=92 Participants Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System n=96 Participants Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Displacement of Skin in the Submentum at Day 90 X-axis	-0.0229 millimeter (mm) Standard Deviation 0.5671	0.0571 millimeter (mm) Standard Deviation 0.5125
Displacement of Skin in the Submentum at Day 90 Y-axis	-0.1693 millimeter (mm) Standard Deviation 0.7151	-0.1352 millimeter (mm) Standard Deviation 0.6336
Displacement of Skin in the Submentum at Day 90 Z-axis	-0.2279 millimeter (mm) Standard Deviation 1.1749	-0.4086 millimeter (mm) Standard Deviation 1.1509

SECONDARY outcome

Timeframe: Day 90

Population: FAS. This endpoint was pre-specified for the treatment group only.

iGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the iGAIS.

Outcome measures

Measure	Treatment With Ulthera DeepSEE System n=96 Participants Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Percentage of Subjects With Any Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Day 90 as Assessed by the Treating Investigator in the Treatment Group	96.8 percentage of subjects	—

SECONDARY outcome

Timeframe: Day 90

Population: FAS. This endpoint was pre-specified for the treatment group only.

sGAIS ratings (-3 to +3 scores; lower scores meant worse outcome) used baseline photographs for comparison. Improvement was defined as a rating of +1, +2, or +3 on the sGAIS.

Outcome measures

Measure	Treatment With Ulthera DeepSEE System n=96 Participants Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Percentage of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) at Day 90 as Assessed by the Subjects in the Treatment Group	94.7 percentage of subjects	—

SECONDARY outcome

Timeframe: Baseline up to Day 90

Population: FAS. This endpoint was pre-specified for the treatment group only. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure.

The subject assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (1 [very dissatisfied] to 4 [very satisfied] scores; Rasch transformed score 0-100; higher scores meant better outcome).

Outcome measures

Measure	Treatment With Ulthera DeepSEE System n=94 Participants Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90, as Assessed by Subjects in Treatment Group	30.3 score on a scale Standard Deviation 23.39	—

SECONDARY outcome

Timeframe: From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180)

Population: SES.

Outcome measures

Measure	Treatment With Ulthera DeepSEE System n=97 Participants Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System n=96 Participants Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system.
Number of Subjects With at Least One Treatment-related Treatment-emergent Adverse Events (TEAEs)	36 Participants	34 Participants

Adverse Events

Treatment With Ulthera DeepSEE System

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Untreated Control/Delayed-treatment With Ulthera DeepSEE System

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment With Ulthera DeepSEE System n=97 participants at risk Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1 and were followed for 180 days after treatment.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System n=96 participants at risk Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system. Subjects were followed for 90 days after treatment.
Hepatobiliary disorders Cholelithiasis	1.0% 1/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	0.00% 0/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Fractured sacrum	1.0% 1/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	0.00% 0/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
Injury, poisoning and procedural complications Radius fracture	1.0% 1/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	0.00% 0/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric leiomyoma	1.0% 1/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	0.00% 0/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.

Other adverse events

Measure	Treatment With Ulthera DeepSEE System n=97 participants at risk Subjects were randomized to receive a single treatment with Ulthera DeepSEE system at Day 1 and were followed for 180 days after treatment.	Untreated Control/Delayed-treatment With Ulthera DeepSEE System n=96 participants at risk Subjects were randomized and were untreated until Day 90 and then received a single treatment with Ulthera DeepSEE system. Subjects were followed for 90 days after treatment.
General disorders Application site pain	22.7% 22/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	25.0% 24/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
General disorders Application site swelling	16.5% 16/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	3.1% 3/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
General disorders Application site vesicles	9.3% 9/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	3.1% 3/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
General disorders Application site erythema	5.2% 5/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	4.2% 4/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
General disorders Application site discomfort	6.2% 6/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	2.1% 2/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.
Skin and subcutaneous tissue disorders Urticaria	8.2% 8/97 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.	3.1% 3/96 • From first treatment (Day 1) up to end of the study (EOS) (Up to Day 180) SES. The investigator reported adverse events (AEs) systematically at each visit.

Additional Information

Public Disclosure Manager

Merz Aesthetics

Phone: +49 69 1503

Email: Aesthetic.Trials@merz.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
• Publication restrictions are in place

Restriction type: OTHER