Feasibility Study: Lifting and Tightening of the Elbows
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 11/25/2017 |
| Start Date: | September 2011 |
| End Date: | February 2013 |
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on
the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will
be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will
be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the
Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and
post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and
patient satisfaction questionnaires will also be obtained.
Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and
post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and
patient satisfaction questionnaires will also be obtained.
Inclusion Criteria:
- Male or female, age 21 to 65 years.
- Subject in good health.
- Mild to moderate skin laxity on the elbows.
- 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.
- Subjects of childbearing potential must have a negative urine pregnancy test result
and must not be lactating at Visit 1 and be willing and able to use an acceptable
method of birth control
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Excessive subcutaneous fat around the elbows.
- Excessive skin laxity around the elbows.
- Significant scarring in areas to be treated.
- Significant open wounds or lesions in the area to be treated
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