Evaluation of the Ulthera® System for Treatment of the Face and Neck
Stopped early · Not applicable
Conditions studied: Wrinkles, Rhytids, Skin Laxity
In brief
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Key facts
- Study ID
- NCT01713907
- Run by
- Ulthera, Inc
- People needed
- 15
- Starts
- 2011-06-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2017-11-24
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, aged 30 to 65 years.
- Subject in good health.
- Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
- Mild to moderate rhytids in the periorbital or perioral region.
- Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
- Mild to moderate vertical perioral lines
- Mild to moderate marionette lines.
- Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
- 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.
You may not qualify if…
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat on the cheek.
- Excessive skin laxity on the lower face and neck.
- Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
- Excessive hooding with or without redundant skin in the areas to be treated.
Where it is running
- Dermatology, Cosmetic & Laser Surgery — Rockville, Maryland, United States
Full record on ClinicalTrials.gov
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