CompletedNot Applicable

Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

United States24 participantsStarted 2011-06

Plain-language summary

Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

Who can participate

Age range

35 Years – 60 Years

Sex

FEMALE

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: * Female, aged 35 to 60 years. * Subject in good health. * Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté. * 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. * Scarring in areas to be treated. * Tattoos in the areas to be treated. * Patients with ports or defibrillators. * Breast size \>400cc each as measured by water displacement method. * History of breast reduction surgery. * Any open wounds or lesions in the area. * Active and severe inflammatory acne in the region to be treated. * Patients who have a history with keloid formation or hypertropic scarring

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 skin

Timeframe: 90 days post-treatment

Trial details

NCT IDNCT01485107

SponsorUlthera, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-01

View on ClinicalTrials.gov More Skin Laxity of the décolleté trials