N/A
N=37
Evaluation of the Ulthera® System for Treatment of the Brachia
Brachial Ptosis
Bottom Line
View on ClinicalTrials.gov: NCT01713933 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity — 48 percentage of participants improved
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ulthera® System (Device)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Ulthera, Inc
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity |
48 | — |
| SECONDARY Quantitative Improvement in Skin Laxity |
54; 62; 35 | — |
| SECONDARY Change in Dermal Thickness |
0.099; 0.085 | — |
| SECONDARY Change in Dermal Thickness |
0.099; 0.085 | — |
| SECONDARY Overall Aesthetic Improvement |
6.5; 16.1; 48.4; 29; 0; 0 | — |
| SECONDARY Overall Aesthetic Improvement |
6.5; 16.1; 48.4; 29; 0; 0 | — |
| SECONDARY Overall Aesthetic Improvement |
6.5; 16.1; 48.4; 29; 0; 0 | — |
| SECONDARY Patient Satisfaction |
12.9; 64.5; 22.5; 0; 70.9 | — |
| SECONDARY Patient Satisfaction |
12.9; 64.5; 22.5; 0; 70.9 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01713933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.