Trial Outcomes & Findings for A Retrospective Study to Evaluate the Effectiveness of the Ulthera System (NCT NCT01519934)

NCT ID: NCT01519934

Last Updated: 2017-12-18

Results Overview

Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.

• Recruitment status: COMPLETED
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline to 180 days post-treatment
• Results posted on: 2017-12-18

Participant Flow

Subjects who had received an Ulthera treatment to the face and upper neck at two treatment depths at one study site were recruited for study participation.

Participant milestones

Measure	Ulthera-treated Subjects All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.
Overall Study STARTED	48
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Ulthera-treated Subjects All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.
Overall Study Lost to Follow-up	3

Baseline Characteristics

A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

Baseline characteristics by cohort

Measure	Ulthera-treated Subjects n=48 Participants All enrolled subjects will have received an Ulthera treatment prior to enrollment.
Age, Continuous	58 years n=93 Participants
Sex: Female, Male Female	48 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race/Ethnicity, Customized Asian	1 participants n=93 Participants
Race/Ethnicity, Customized Caucasian	42 participants n=93 Participants
Race/Ethnicity, Customized Hispanic/Latino	3 participants n=93 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=93 Participants
Race/Ethnicity, Customized More than one race	1 participants n=93 Participants
Region of Enrollment United States	48 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 180 days post-treatment

Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.

Outcome measures

Measure	Ulthera-treated Subjects n=45 Participants All enrolled subjects will have received an Ulthera treatment prior to enrollment.
Improvement in Overall Lifting and Tightening of the Skin	67 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 180 days post-treatment

Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:

1. = Very Much Improved

2. = Much Improved

3. = Improved

4. = No Change

5. = Worse

Outcome measures

Measure	Ulthera-treated Subjects n=45 Participants All enrolled subjects will have received an Ulthera treatment prior to enrollment.
Overall Aesthetic Improvement Investigator GAIS	78 percentage of participants
Overall Aesthetic Improvement Subject GAIS	78 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 180 days post-treatment

Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.

Outcome measures

Measure	Ulthera-treated Subjects n=45 Participants All enrolled subjects will have received an Ulthera treatment prior to enrollment.
Subject Perception of Age	60 percentage of participants

SECONDARY outcome

Timeframe: 180 days post-treatment

Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.

Outcome measures

Measure	Ulthera-treated Subjects n=45 Participants All enrolled subjects will have received an Ulthera treatment prior to enrollment.
Patient Satisfaction	60 percentage of participants

Adverse Events

Ulthera-treated Subjects

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: clinicaltrials@merz.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place