Trial Outcomes & Findings for Evaluation of the Ulthera System for the Treatment of the Decolletage (NCT NCT01713686)

Last Updated: 2017-12-11

Results Overview

Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

90 Days post-treatment

Results posted on

2017-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Ulthera System Treatment A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Overall Study STARTED	125
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Ulthera System Treatment A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Overall Study Lost to Follow-up	9
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Evaluation of the Ulthera System for the Treatment of the Decolletage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ulthera System Treatment n=125 Participants A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Age, Continuous	56.7 years n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	117 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	7 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Fitzpatrick's Sun-Reactive Skin Type Type I	1 participants n=5 Participants
Fitzpatrick's Sun-Reactive Skin Type Type II	60 participants n=5 Participants
Fitzpatrick's Sun-Reactive Skin Type Type III	52 participants n=5 Participants
Fitzpatrick's Sun-Reactive Skin Type Type IV	12 participants n=5 Participants
Fitzpatrick's Sun-Reactive Skin Type Type V	0 participants n=5 Participants
Fitzpatrick's Sun-Reactive Skin Type Type VI	0 participants n=5 Participants
BMI	24.7 kg/m^2 n=5 Participants
Fabi/Bolton Score Fabi/Bolton Score 1	0 participants n=5 Participants
Fabi/Bolton Score Fabi/Bolton Score 2	0 participants n=5 Participants
Fabi/Bolton Score Fabi/Bolton Score 3	0 participants n=5 Participants
Fabi/Bolton Score Fabi/Bolton Score 4	111 participants n=5 Participants
Fabi/Bolton Score Fabi/Bolton Score 5	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 Days post-treatment

Population: The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as 'missing' by the statistician and were not included in the denominator for the masked assessment analyses.

Outcome measures

Outcome measures
Measure	Ulthera System Treatment n=113 Participants A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment Improvement	69.9 percentage of participants
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment No change	15.9 percentage of participants
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment Incorrect	14.2 percentage of participants

PRIMARY outcome

Timeframe: 180 days post treatment

Population: The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.

Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.

Outcome measures

Outcome measures
Measure	Ulthera System Treatment n=116 Participants A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment Improved	66.4 percentage of participants
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment No Change	11.2 percentage of participants
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment Incorrect	22.4 percentage of participants

SECONDARY outcome

Timeframe: 90 days post-treatment

Population: This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.

The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse The scale was completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and * Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. "Improved" = Very Much Improved + Much Improved + Improved

Outcome measures

Outcome measures
Measure	Ulthera System Treatment n=116 Participants A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Overall Aesthetic Improvement at 90 Days Post-treatment Improved	75.1 percentage of participants
Overall Aesthetic Improvement at 90 Days Post-treatment No change	24.1 percentage of participants
Overall Aesthetic Improvement at 90 Days Post-treatment Worse	0.9 percentage of participants

SECONDARY outcome

Timeframe: 180 days post-treatment

Population: Analysis population was based the number of subjects completing a 180 day follow-up visit.

The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse The scale was completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and * Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. "Improved" = Very Much Improved + Much Improved + Improved

Outcome measures

Outcome measures
Measure	Ulthera System Treatment n=110 Participants A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Overall Aesthetic Improvement at 180 Days Post-treatment Improved	66.4 percentage of participants
Overall Aesthetic Improvement at 180 Days Post-treatment No Change	30.0 percentage of participants
Overall Aesthetic Improvement at 180 Days Post-treatment Worse	3.6 percentage of participants

SECONDARY outcome

Timeframe: 90 days post-treatment

Population: This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit.

Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: 1. Very Satisfied 2. Satisfied 3. Neither Satisfied or Dissatisfied 4. Dissatisfied 5. Very Dissatisfied "Satisfied"= Very Satisfied + Satisfied "Dissatisfied"=Dissatisfied + Very Dissatisfied

Outcome measures

Outcome measures
Measure	Ulthera System Treatment n=116 Participants A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Subject Satisfaction at 90 Days Post-treatment Neither Satisfied or Dissatisfied	29.3 percentage of participants
Subject Satisfaction at 90 Days Post-treatment Dissatisfied	5.2 percentage of participants
Subject Satisfaction at 90 Days Post-treatment Satisfied	65.5 percentage of participants

SECONDARY outcome

Timeframe: 180 days post-treatment

Population: This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit.

Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: 1. Very Satisfied 2. Satisfied 3. Neither Satisfied or Dissatisfied 4. Dissatisfied 5. Very Dissatisfied "Satisfied" = Very Satisfied + Satisfied "Dissatisfied" = Dissatisfied + Very Dissatisfied

Outcome measures

Outcome measures
Measure	Ulthera System Treatment n=110 Participants A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Subject Satisfaction at 180 Days Post-treatment Satisfied (satisfied and very satisfied)	62.7 percentage of participants
Subject Satisfaction at 180 Days Post-treatment Neither Satisfied nor Dissatisfied	22.7 percentage of participants
Subject Satisfaction at 180 Days Post-treatment Dissatisfied (dissatisfied and very dissatisfied)	14.5 percentage of participants

Adverse Events

Ulthera System Treatment

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ulthera System Treatment n=125 participants at risk A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths. Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin
Skin and subcutaneous tissue disorders Tenderness	36.0% 45/125 • Number of events 45 • Adverse events were followed for up to 6 months post-treatment or until event resolution.
Skin and subcutaneous tissue disorders Bruising	17.6% 22/125 • Number of events 22 • Adverse events were followed for up to 6 months post-treatment or until event resolution.
Skin and subcutaneous tissue disorders Pruitus	12.8% 16/125 • Number of events 16 • Adverse events were followed for up to 6 months post-treatment or until event resolution.

Additional Information

Public Disclosure Manager

Merz Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place