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This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.
This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultherapyâ„¢ treatment | Experimental | Each enrolled subject will receive a bilateral Ultherapyâ„¢ treatment of the upper arms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera® System | Device | Focused ultrasound energy delivered below the surface of the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity | Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. | Baseline to 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Improvement in Skin Laxity | Assess change in brachial volume based on brachial tissue measurements. | Baseline to 90 days post-treatment |
| Change in Dermal Thickness | Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Sasaki, MD FACS | Sasaki Advanced Aesthetic Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sasaki Advanced Aesthetic Medical Center | Pasadena | California | 91105 | United States |
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Enrollment opened 6/29/2011 and the last subject was treated 11/28/2011. Subjects were recruited from the site's patient database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultherapy® Treatment | Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Three subjects excluded due to subject withdrawal. One subject excluded from results analyses as an outlier, with a high Body Mass Index (BMI) and substantial weight gain during the study period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultherapy® Treatment | Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms |
| 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 Obtaining Lift and Tightening of Brachial Skin Laxity | Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. | Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up. | Posted | Number | percentage of participants improved | Baseline to 90 days 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 | Ultherapy® Treatment | Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms |
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- Poor subject selection (high BMI with large volume arms enrolled rather than subjects with laxity and wrinkled skin)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals | clinicaltrials@merz.com |
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| Baseline to 90 days post-treatment |
| Change in Dermal Thickness | Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated. | Baseline to180 days post-treatment |
| Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
| Baseline to 60 days post-treatment |
| Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
| Baseline to 90 days post-treatment |
| Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
| Baseline to180 days post-treatment |
| Patient Satisfaction | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. | Baseline to 90 days post-treatment |
| Patient Satisfaction | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. | Baseline to 180 days post-treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Quantitative Improvement in Skin Laxity | Assess change in brachial volume based on brachial tissue measurements. | Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up. | Posted | Number | percentage of participants improved | Baseline to 90 days post-treatment |
|
|
|
| Secondary | Change in Dermal Thickness | Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated. | Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up. | Posted | Mean | Full Range | Millimeters | Baseline to 90 days post-treatment |
|
|
|
| Secondary | Change in Dermal Thickness | Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated. | Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. | Posted | Mean | Full Range | Millimeters | Baseline to180 days post-treatment |
|
|
|
| Secondary | Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
| Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. | Posted | Number | Percentage of Participants | Baseline to 60 days post-treatment |
|
|
|
| Secondary | Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
| Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up. | Posted | Number | Percentage of Participants | Baseline to 90 days post-treatment |
|
|
|
| Secondary | Overall Aesthetic Improvement | Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
| Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. | Posted | Number | Percentage of Participants | Baseline to180 days post-treatment |
|
|
|
| Secondary | Patient Satisfaction | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. | wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up. | Posted | Number | Percentage of Participants | Baseline to 90 days post-treatment |
|
|
|
| Secondary | Patient Satisfaction | Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. | Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. | Posted | Number | Percentage of Participants | Baseline to 180 days post-treatment |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Subject GAIS No Change |
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| Subject GAIS Worse |
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| Physician GAIS Very Much Improved |
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| Physician GAIS Much Improved |
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| Physician GAIS Improved |
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| Physician GAIS No Change |
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| Physician GAIS Worse |
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| Title | Measurements |
|---|---|
|
| Subject GAIS No Change |
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| Subject GAIS Worse |
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| Physician GAIS Very Much Improved |
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| Physician GAIS Much Improved |
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| Physician GAIS Improved |
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| Physician GAIS No Change |
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| Physician GAIS Worse |
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| Title | Measurements |
|---|---|
|
| Subject GAIS No Change |
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| Subject GAIS Worse |
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| Physician GAIS Very Much Improved |
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| Physician GAIS Much Improved |
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| Physician GAIS Improved |
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| Physician GAIS No Change |
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| Physician GAIS Worse |
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| Title | Measurements |
|---|---|
|
| Very Dissatisfied |
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| Improvement Noticed |
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| Title | Measurements |
|---|---|
|
| Very Dissatisfied |
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| Improvement Noticed |
|