Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 25 - 60 |
| Updated: | 11/25/2017 |
| Start Date: | March 2012 |
| End Date: | April 2013 |
Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue
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.
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 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.
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.
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.
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