Feasibility Study: Lifting and Tightening of the Elbows (NCT01708382) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study: Lifting and Tightening of the Elbows
United States21 participantsStarted 2011-09
Plain-language summary
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.
Who can participate
Age range21 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Overall improvement of skin laxity in the areas treated