Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 25 - 60 |
| Updated: | 11/25/2017 |
| Start Date: | April 2012 |
| End Date: | July 2013 |
Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach
All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained
pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects
will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects
will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera®
System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and
tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at
study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction
questionnaires will also be obtained.
System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and
tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at
study follow-up visits. Global Aesthetic Improvement Scale scores 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 area(s) to be treated.
- Understands and accepts the obligation not to undergo any other procedures in the
area(s) 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 area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
- Significant scarring in area(s) to be treated.
- Open wounds or lesions in the area(s) to be treated.
- Severe or cystic acne on the area(s) to be treated.
- Presence of a metal stent or implant in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- BMI equal to and greater than 30.
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