CompletedNot Applicable

A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

United States48 participantsStarted 2011-10

Plain-language summary

Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.

Who can participate

Age range

25 Years – 85 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, age 25-85 years. * Subject in good health. * Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken. * Willingness and ability to comply with protocol requirements, including returning for follow-up visits. * Absence of physical or psychological conditions unacceptable to the investigator. Exclusion Criteria: * Presence of an active systemic or local skin disease that may affect wound healing. * Significant scarring in areas treated. * Open wounds or lesions in the areas treated. * Severe or cystic acne on the areas treated. * Inability to understand the protocol or to give informed consent.

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

Improvement in Overall Lifting and Tightening of the Skin

Timeframe: Baseline to 180 days post-treatment

Trial details

NCT IDNCT01519934

SponsorUlthera, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-04

Results submitted2013-12-30

View on ClinicalTrials.gov More Skin Laxity trials

Who can participate

Age range

25 Years – 85 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.