Chest Wrinkles
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Micro-focused Ultrasound with Visualization (MFU-V)
Brief summary
This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Interventions
DEVICEUlthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Sponsors
Ulthera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, aged 35 to 70 years. * Subject in good health. * Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale. * Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * Willingness and ability to comply with protocol requirements. * Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating. * Absence of physical conditions unacceptable to the investigator. * Willingness and ability to provide written consent for study-required photography. * Willingness and ability to provide written informed consent.
Exclusion criteria
* Presence of an active systemic or local skin disease that may affect wound healing. * Scarring in areas to be treated. * Tattoos in the areas to be treated. * Patients with ports or defibrillators. * Any open wounds or lesions in the area. * Active and severe inflammatory acne in the region to be treated. * Patients who have a history with keloid formation or hypertrophic scarring. * Inability to understand the protocol or to give informed consent. * Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study. * Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin. * History of chronic drug or alcohol abuse. * History of autoimmune disease. * Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device. * Subjects who anticipate the need for surgery or overnight hospitalization during the study. * Subjects who have a history of poor cooperation, noncompliance with medical treatment, or unreliability. * Concurrent enrollment in any study involving the use of investigational devices or drugs. * Current smoker or history of smoking in the last one year. * History of using the following prescription medications: 1. Topical Retinoids to the area within the past two weeks; 2. Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix). 3. Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment | 90 Days post-treatment | 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. |
| Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment | 180 days post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Aesthetic Improvement at 90 Days Post-treatment | 90 days post-treatment | 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 |
| Overall Aesthetic Improvement at 180 Days Post-treatment | 180 days post-treatment | 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 |
| Subject Satisfaction at 90 Days Post-treatment | 90 days post-treatment | 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 |
| Subject Satisfaction at 180 Days Post-treatment | 180 days post-treatment | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Ulthera System Treatment |
|---|---|
| Age, Continuous | 56.7 years |
| BMI | 24.7 kg/m^2 |
| Fabi/Bolton Score Fabi/Bolton Score 1 | 0 participants |
| Fabi/Bolton Score Fabi/Bolton Score 2 | 0 participants |
| Fabi/Bolton Score Fabi/Bolton Score 3 | 0 participants |
| Fabi/Bolton Score Fabi/Bolton Score 4 | 111 participants |
| Fabi/Bolton Score Fabi/Bolton Score 5 | 14 participants |
| Fitzpatrick's Sun-Reactive Skin Type Type I | 1 participants |
| Fitzpatrick's Sun-Reactive Skin Type Type II | 60 participants |
| Fitzpatrick's Sun-Reactive Skin Type Type III | 52 participants |
| Fitzpatrick's Sun-Reactive Skin Type Type IV | 12 participants |
| Fitzpatrick's Sun-Reactive Skin Type Type V | 0 participants |
| Fitzpatrick's Sun-Reactive Skin Type Type VI | 0 participants |
| Race/Ethnicity, Customized Caucasian | 117 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 7 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Sex: Female, Male Female | 125 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 83 / 125 |
| serious Total, serious adverse events | 0 / 125 |
Outcome results
Primary
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulthera System Treatment | Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment | Improved | 66.4 percentage of participants |
| Ulthera System Treatment | Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment | No Change | 11.2 percentage of participants |
| Ulthera System Treatment | Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment | Incorrect | 22.4 percentage of participants |
Primary
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulthera System Treatment | Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment | Improvement | 69.9 percentage of participants |
| Ulthera System Treatment | Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment | No change | 15.9 percentage of participants |
| Ulthera System Treatment | Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment | Incorrect | 14.2 percentage of participants |
Secondary
Overall Aesthetic Improvement at 180 Days Post-treatment
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
Time frame: 180 days post-treatment
Population: Analysis population was based the number of subjects completing a 180 day follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulthera System Treatment | Overall Aesthetic Improvement at 180 Days Post-treatment | Worse | 3.6 percentage of participants |
| Ulthera System Treatment | Overall Aesthetic Improvement at 180 Days Post-treatment | Improved | 66.4 percentage of participants |
| Ulthera System Treatment | Overall Aesthetic Improvement at 180 Days Post-treatment | No Change | 30.0 percentage of participants |
Secondary
Overall Aesthetic Improvement at 90 Days Post-treatment
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
Time frame: 90 days post-treatment
Population: This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulthera System Treatment | Overall Aesthetic Improvement at 90 Days Post-treatment | Improved | 75.1 percentage of participants |
| Ulthera System Treatment | Overall Aesthetic Improvement at 90 Days Post-treatment | No change | 24.1 percentage of participants |
| Ulthera System Treatment | Overall Aesthetic Improvement at 90 Days Post-treatment | Worse | 0.9 percentage of participants |
Secondary
Subject Satisfaction at 180 Days Post-treatment
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulthera System Treatment | Subject Satisfaction at 180 Days Post-treatment | Neither Satisfied nor Dissatisfied | 22.7 percentage of participants |
| Ulthera System Treatment | Subject Satisfaction at 180 Days Post-treatment | Satisfied (satisfied and very satisfied) | 62.7 percentage of participants |
| Ulthera System Treatment | Subject Satisfaction at 180 Days Post-treatment | Dissatisfied (dissatisfied and very dissatisfied) | 14.5 percentage of participants |
Secondary
Subject Satisfaction at 90 Days Post-treatment
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulthera System Treatment | Subject Satisfaction at 90 Days Post-treatment | Satisfied | 65.5 percentage of participants |
| Ulthera System Treatment | Subject Satisfaction at 90 Days Post-treatment | Neither Satisfied or Dissatisfied | 29.3 percentage of participants |
| Ulthera System Treatment | Subject Satisfaction at 90 Days Post-treatment | Dissatisfied | 5.2 percentage of participants |