Trial Outcomes & Findings for Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue (NCT NCT01368835)

Results Overview

The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

90D

Results posted on

2017-12-13

Participant Flow

Recruitment from June 30, 2010 to August 31, 2010.

Male or Female, aged 30 to 60 years. Desire to lift and tighten cheek tissue, improve jawline definition and/or submental skin laxity.

Participant milestones

Participant milestones
Measure	Ulthera Treatment Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.
Overall Study STARTED	103
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Ulthera Treatment Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.
Overall Study Inclusion criteria/photography quality	22
Overall Study Lost to Follow-up	11

Baseline Characteristics

Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ulthera Treatment n=70 Participants Treatment to the lower face and submental region.
Age, Continuous	49.5 years n=93 Participants
Sex: Female, Male Female	57 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Region of Enrollment United States	70 participants n=93 Participants
Fitzpatrick Skin Type Skin Type I	9 # of Participants n=93 Participants
Fitzpatrick Skin Type Skin Type II	46 # of Participants n=93 Participants
Fitzpatrick Skin Type Skin Type III	12 # of Participants n=93 Participants
Fitzpatrick Skin Type Skin Type IV	2 # of Participants n=93 Participants
Fitzpatrick Skin Type Skin Type V	1 # of Participants n=93 Participants

PRIMARY outcome

Timeframe: 90D

Population: The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants, for a masked assessment.

The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.

Outcome measures

Outcome measures
Measure	Ulthera Treatment n=70 Participants Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.	68.60 percentage of participants improved

SECONDARY outcome

Timeframe: 90D

Population: The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants.

The percentage of participants assessed as having an improvement in tissue lift, i.e., \>20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.

Outcome measures

Outcome measures
Measure	Ulthera Treatment n=70 Participants Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
Change in Submental and Neck Skin Laxity by Quantitative Analysis	72.9 percentage of participants improved

SECONDARY outcome

Timeframe: 90D

Population: The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available.

Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.

Outcome measures

Outcome measures
Measure	Ulthera Treatment n=70 Participants Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
Patient Satisfaction Questionnaire	67 percentage of participants improved

OTHER_PRE_SPECIFIED outcome

Timeframe: During Ulthera study treatment

Population: Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed.

Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.

Outcome measures

Outcome measures
Measure	Ulthera Treatment n=70 Participants Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
Subject Assessment of Pain	6.13 Average NRS score Interval 1.0 to 10.0

Adverse Events

Ulthera Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Public Disclosure Manager

Merz Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60