CompletedNot Applicable

Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

United States20 participantsStarted 2015-08-20

Plain-language summary

Evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs) produced during a treatment with the Ulthera System make contact with anatomical layers of the skin and underlying tissues.

Who can participate

Age range

30 Years – 55 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

. Subject in good health.
. Mild to moderate skin laxity on the area(s) to be treated.
. Subject is pre-menopausal (treated in first week of cycle) or post-menopausal.
. Subject forehead's sub-dermal layer is at least a depth of 4.5mm using the 7-4.5mm transducer.
. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Exclusion criteria

. 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 the following conditions is documented on the medical history:
. Absence of physical or psychological conditions unacceptable to the investigator.
. Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. After all study treatments are completed, limited acute NSAID use is allowed i.e a maximum of 2-3 doses, in any 2 weeks period.

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

Determine if There is a Correlation Between D90 Quantitative Efficacy Results of the Eyebrow and Lower Face Region With Where the TCPs Produced During Ultherapy Treatment Make Contact With Anatomical Layers of the Skin and Underlying Tissues.

Timeframe: Day 90 post treatment

Trial details

NCT IDNCT03599349

SponsorUlthera, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07-13

Results submitted2019-05-17

View on ClinicalTrials.gov More Facial and Neck Skin Laxity trials