Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ulthera, Inc
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Severe or cystic acne in the treatment areas.
Outcomes
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
- Change in Dermal Thickness(Baseline to180 days post-treatment)
- Patient Satisfaction(Baseline to 180 days post-treatment)
- Quantitative Improvement in Skin Laxity(Baseline to 90 days post-treatment)
- Overall Aesthetic Improvement(Baseline to180 days post-treatment)