CompletedNot Applicable

Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

United States71 participantsStarted 2011-03

Plain-language summary

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

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. * Skin laxity in the lower face and neck. * Willingness and ability to comply with protocol requirements and return for follow-up visits. * Provides written informed consent and HIPAA authorization. Exclusion Criteria: * Pregnant or lactating. * Presence of an active systemic or local skin disease that may affect wound healing. * Severe solar elastosis. * Excessive subcutaneous fat in the face and lower neck. * Excessive skin laxity on the face and neck. * Significant scarring in areas to be treated. * Significant open facial wounds or lesions. * Severe or cystic acne on the face. * Presence of a metal stent or implant in the facial area to be treated.

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 Jowls and/or Neck Laxity

Timeframe: 90 Days post-treatment

Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP

Timeframe: 90 Days post-treatment

Trial details

NCT IDNCT01368874

SponsorUlthera, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2013-06-03

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