Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Laxity
- Sponsor
- Ulthera, Inc
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Improvement laxity/crepiness and texture of abdominal tissue
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Enrolled subjects will receive one UltherapyTM treatment on the abdomen. 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.
Detailed Description
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 25 to 60 years.
- •Subject in good health.
- •Skin laxity in the abdomen
- •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 abdomen.
- •Excessive skin laxity on the abdomen.
- •Significant scarring in areas to be treated.
- •Open wounds or lesions in the area to be treated.
- •Inability to understand the protocol or to give informed consent.
- •BMI equal to and greater than 30.
Outcomes
Primary Outcomes
Improvement laxity/crepiness and texture of abdominal tissue
Time Frame: 90 days post-treatment
Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline
Secondary Outcomes
- Overall aesthetic improvement(180 days post-treatment)