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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera-treated subjects | All enrolled subjects will have received an Ulthera treatment prior to enrollment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 180 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Baseline to 180 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of males and females from the investigator's practice between 25 and 85 years of age, who have received an Ultherapy™ treatment on or prior to October 1, 2011, who had pre-treatment baseline photographs taken, and who have chosen to participate in this clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel Goldman, MD | Dermatology Cosmetic Laser Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Cosmetic Laser Associates | San Diego | California | 92121 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects who had received a dual depth Ulthera treatment to the face and upper neck prior to enrollment and met all entrance criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ulthera-treated Subjects | All enrolled subjects will have received an Ulthera treatment prior to enrollment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | Baseline to 180 days post-treatment |
|
Adverse events were collected from enrollment to 6 months post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ulthera-treated Subjects | All enrolled subjects will have received an Ulthera treatment prior to enrollment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| Subject Perception of Age | Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire. | Baseline to 180 days post-treatment |
| Patient Satisfaction | Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire. | 180 days post-treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | 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:
| Posted | Number | percentage of participants | Baseline to 180 days post-treatment |
|
|
|
| Secondary | Subject Perception of Age | Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire. | Posted | Number | percentage of participants | Baseline to 180 days post-treatment |
|
|
|
| Secondary | Patient Satisfaction | Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire. | Posted | Number | percentage of participants | 180 days post-treatment |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |