Feasibility Study: Lifting and Tightening Neck Skin in Patients
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 11/25/2017 |
| Start Date: | August 2010 |
| End Date: | August 2012 |
Feasibility Study: Evaluation Of The Ulthera™ System For Obtaining Lift And Tightening Of The Neck Skin In Patients With A History Of Submentoplasty And Or Rhytidectomy Vs Patients Naïve To Submentoplasty Or Rhytidectomy - A Feasibility Study
Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the
lower two thirds of the face and neck. Subjects will be equally grouped into those with a
history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or
rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment.
Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each
follow-up visit.
lower two thirds of the face and neck. Subjects will be equally grouped into those with a
history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or
rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment.
Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each
follow-up visit.
This is a prospective single center study. Subjects will be enrolled one per group as they
present. Efficacy will be determined by the change in submental volume and cervicomental
angle. GAIS and patient satisfaction questionnaires will also be obtained.
present. Efficacy will be determined by the change in submental volume and cervicomental
angle. GAIS and patient satisfaction questionnaires will also be obtained.
Inclusion Criteria:
- Male or female, aged 30 to 65 years
- Subject in good health
- Body Mass index of less than 30
- Present with unwanted skin laxity in the submental area as demonstrated by a grade 2
or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental
angle
- Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months
previous to enrollment and not to exceed 120 months prior to enrollment
- Understands and accepts the obligation not to receive any other procedures in the
submental areas thru the 6 month follow up visit
- 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 at
Visit 1 and be willing able to use an acceptable method of birth control
Exclusion Criteria:
- Pregnant, lactating or planning to become pregnant and or not using a reliable form of
birth control
- Has an active systemic or local skin disease that may alter wound healing
- Subjects with a prior cosmetic or medical history of submentoplasty and or
Rhytidectomy within the last 12 months or greater than 120 months
- Subjects with a prior cosmetic or medical history of submentoplasty and or
Rhytidectomy
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