Ultherapy for Buttock Lift

Inclusion Criteria

• •1. Female, age 18 to 65 years.
• •2. Subject in good health.
• •3. Mild to moderate buttock ptosis based on Investigator evaluation.
• •4. BMI \<25.
• •5. No history of weight gain or loss of greater than 10 pounds within the past year.
• •6. No planned weight loss or gain for the duration of the study.
• •7. No pregnancy within the past year.
• •8. Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. If a chronic user, a washout period of 4 weeks is required prior to study treatment #1. Washout period for limited acute NSAID use, i.e., a maximum of 2-3 doses, is required in the 2 weeks prior to any study treatment visit.
• •9. No immunosuppressive therapy, e.g., oral steroid treatment, within the past 4 weeks and during the entire post-treatment study period. Washout period, if recent use, for 4 weeks prior to study treatment #1.
• •10. Subject must desire improvement of her buttock ptosis as demonstrated by a Dissatisfaction response on a baseline Patient Satisfaction Questionnaire, i.e., Dissatisfied, Neither Satisfied or Dissatisfied, Slightly Satisfied, Satisfied, Very Satisfied.
• •11. Willingness to refrain from receiving spray tans or using self-tanning lotions from mid-thigh to waist within 2 weeks of any study assessments for the duration of the trial.
• •12. Willingness to avoid as much as possible, direct and prolonged sun exposure from mid-thigh to waist for the duration of the study.
• •13. Willingness to refrain from topical steroid use, tretinoin, caffeine cream and other prescription or over-the-counter cellulite reduction topicals to the affected area 2 weeks prior to study treatment #1 and for the duration of the study period.
• •14. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• •15. 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.
• •16. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Baseline Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• •1. Postmenopausal for at least 12 months prior to study;
• •2. Without a uterus and/or both ovaries; or
• •3. Bilateral tubal ligation at least six months prior to study enrollment.
• •17. Absence of physical or psychological conditions unacceptable to the investigator.
• •18. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures.
• •19. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.