Feasibility Study: Lifting and Tightening Neck Skin in Patients (NCT01708928) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study: Lifting and Tightening Neck Skin in Patients
United States30 participantsStarted 2010-08
Plain-language summary
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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.