Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) … (NCT03351335) | Clinical Trial Compass
CompletedNot Applicable
Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
United States60 participantsStarted 2017-08-10
Plain-language summary
To evaluate the Ulthera® System for lifting submental (under the chin) and neck tissue in Chinese patients
Who can participate
Age range
35 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
. Both parents of full Chinese decent.
. Mild to moderate skin laxity of the submental (under the chin) and neck tissue as determined by the physician and trained assessors.
. Adequate menton area to allow for quantitative analysis, as confirmed by photography images.
. Willingness and ability to comply with protocol requirements, including returning for follow-up visit and abstaining from any other procedures in the areas to be treated through the follow-up period.
. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
. Postmenopausal with last menstrual bleeding at least 12 months prior to study; and
. Without a uterus and/or both ovaries.
. Willing to take 600mg Ibuprofen as pre-treatment medication, at least 60 minutes but not more than two hours prior to study treatment.
Exclusion criteria
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.
What they're measuring
1
Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment
. Presence of an active systemic or local skin disease that may affect wound healing.
. Presence of any hemorrhagic disorder or hemostatic dysfunction, herpes simplex, diabetes, epilepsy, bell's palsy or any physical or psychological condition that is deemed unacceptable by the investigator for participation in this study.
. 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 the area(s) to be treated that would interfere with assessing results.
. Open wounds or lesions in the area(s) to be treated.
. Severe or cystic acne on the area(s) to be treated.