Evaluation of the Ulthera® System for Treatment of the Face and Neck (NCT01713907) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the Ulthera® System for Treatment of the Face and Neck
Stopped: Inadequate study staff to appropriately manage trial.
United States15 participantsStarted 2011-06
Plain-language summary
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.
Who can participate
Age range30 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
What they're measuring
1
Improvement in facial wrinkles and lifting and tightening of skin