Sasaki Advanced Aesthetic Medical Center
Pasadena, California, 91105, United States
Completed
NCT Number: NCT01713933
Evaluation of the Ulthera® System for Treatment of the Brachia
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.
Completed
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Conditions
Age range
19 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female, aged 19 - 55 years.
- Subject in good health.
- Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
- Mild to moderate laxity of the upper arm.
- Mild to moderate subcutaneous fat of the upper arm.
- Mild crepiness of the skin of the upper arm.
- 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, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Exclusion criteria
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the upper arm.
- Excessive skin laxity in the upper arm.
- Significant scarring in areas to be treated.
- Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.
Treatment and study plan
Ulthera® System
DeviceFocused ultrasound energy delivered below the surface of the skin.
Other names: Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Primary outcomes
-
Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
Time frame: Baseline to 90 days post-treatment
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.
Secondary outcomes
-
Quantitative Improvement in Skin Laxity
Time frame: Baseline to 90 days post-treatment
Assess change in brachial volume based on brachial tissue measurements.
-
Change in Dermal Thickness
Time frame: Baseline to 90 days post-treatment
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.
-
Change in Dermal Thickness
Time frame: Baseline to180 days post-treatment
Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.
-
Overall Aesthetic Improvement
Time frame: Baseline to 60 days post-treatment
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:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
-
Overall Aesthetic Improvement
Time frame: Baseline to 90 days post-treatment
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:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
-
Overall Aesthetic Improvement
Time frame: Baseline to180 days post-treatment
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:
- - Very Much Improved
- - Much Improved
- - Improved
- - No Change
- - Worse
-
Patient Satisfaction
Time frame: Baseline to 90 days post-treatment
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.
-
Patient Satisfaction
Time frame: Baseline to 180 days post-treatment
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.
Sponsors and collaborators
Lead sponsor
Ulthera, Inc
Industry
Registry information
Official study title
Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 25, 2012
- Registry last updated
- Dec 11, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.