Décolleté Wrinkles
Conditions
Brief summary
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
Interventions
Micro-focused ultrasound delivered below the surface of the skin.
Sponsors
Ulthera, Inc
Merz North America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention.
Exclusion criteria
* Presence of an active systemic or local skin disease that may affect wound healing. * Scarring in area(s) to be treated. * Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated. * Breast implants or is planning to receive breast implants during the study. * Inability to take pre-treatment medications due to a pre-existing condition, medication allergy, or medical issue that, at the discretion of the treating investigator, is contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90 | Day 90 | Improvement in lines and wrinkles of the décolleté were determined 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180 | Day 180 | Improvement in lines and wrinkles of the décolleté were determined after comparing Day 180 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 180 photographs as improved compared to baseline. |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | From Day 1 up to end of the study (Up to Day 180) | TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 10 investigational sites in the United States.
Pre-assignment details
Of the 153 screened subjects, 54 subjects exited as screen failures and 99 subjects were enrolled to receive a single Octave-Ultherapy treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Octave-Ultherapy Treatment Subjects received a single Ultherapy treatment with the Octave system on Day 1. | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | Octave-Ultherapy Treatment |
|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 6.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Sex: Female, Male Female | 99 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 99 |
| other Total, other adverse events | 6 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Primary
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90
Improvement in lines and wrinkles of the décolleté were determined 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.
Time frame: Day 90
Population: Intent-to-treat (ITT) population included all subjects who were enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Octave-Ultherapy Treatment | Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90 | 62.2 percentage of subjects |
Secondary
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.
Time frame: From Day 1 up to end of the study (Up to Day 180)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Octave-Ultherapy Treatment | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 17 Participants |
Secondary
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180
Improvement in lines and wrinkles of the décolleté were determined after comparing Day 180 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 180 photographs as improved compared to baseline.
Time frame: Day 180
Population: ITT. Here overall number of subjects analyzed were subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Octave-Ultherapy Treatment | Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180 | 68.0 percentage of subjects |