Skin Laxity, Wrinkles
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Brief summary
Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.
Detailed description
This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
Interventions
None listed
Sponsors
Ulthera, Inc
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, age 25-85 years. * Subject in good health. * Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken. * Willingness and ability to comply with protocol requirements, including returning for follow-up visits. * Absence of physical or psychological conditions unacceptable to the investigator.
Exclusion criteria
* Presence of an active systemic or local skin disease that may affect wound healing. * Significant scarring in areas treated. * Open wounds or lesions in the areas treated. * Severe or cystic acne on the areas treated. * Inability to understand the protocol or to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Overall Lifting and Tightening of the Skin | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Aesthetic Improvement | 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 |
| Subject Perception of Age | Baseline to 180 days post-treatment | Percentage of subjects rated as looking younger as measured using a Subject Perception of Age questionnaire. |
| Patient Satisfaction | 180 days post-treatment | Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ulthera-treated Subjects All enrolled subjects will have received an Ulthera treatment prior to enrollment. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Ulthera-treated Subjects |
|---|---|
| Age, Continuous | 58 years |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 42 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 participants |
| Race/Ethnicity, Customized More than one race | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 48 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 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Improvement in Overall Lifting and Tightening of the Skin
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.
Time frame: Baseline to 180 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ulthera-treated Subjects | Improvement in Overall Lifting and Tightening of the Skin | 67 percentage of participants |
Secondary
Overall Aesthetic Improvement
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
Time frame: Baseline to 180 days post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulthera-treated Subjects | Overall Aesthetic Improvement | Investigator GAIS | 78 percentage of participants |
| Ulthera-treated Subjects | Overall Aesthetic Improvement | Subject GAIS | 78 percentage of participants |
Secondary
Patient Satisfaction
Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.
Time frame: 180 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ulthera-treated Subjects | Patient Satisfaction | 60 percentage of participants |
Secondary
Subject Perception of Age
Percentage of subjects rated as looking younger as measured using a Subject Perception of Age questionnaire.
Time frame: Baseline to 180 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ulthera-treated Subjects | Subject Perception of Age | 60 percentage of participants |