CompletedNot Applicable

Condition of Submental Fullness and Treatment Outcomes Registry

United States, Canada1,029 participantsStarted 2015-05-11

Plain-language summary

The primary objective of this registry is to develop a comprehensive understanding of the condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current clinical practice, and the risks and benefits associated with its treatment.

Who can participate

Age range

18 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: * Adult male and female patients, aged 18 years and above, presenting with SM fullness due to the accumulation of unwanted SMF, and considered by their treating physician to be a candidate to receive treatment of SM fullness by reduction of SMF, if the patient decides * Signed informed consent by the patient, obtained before any study-related activities are undertaken * Willing to complete all patient assessment questionnaires * Signed release form by the patient, permitting abstraction of the patient's medical records at baseline and during participation in the registry Exclusion Criteria: * Severe skin laxity, defined as superficial wrinkling, loose skin separated from deeper neck structures, and/or marked skin redundancy (draping and/or sagging), per the physician's judgment * Any other cause of fullness in the SM area (eg, thyroid enlargement, cervical adenopathy) other than localized SMF * Participating in an interventional clinical study, currently or within 30 days before enrollment

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

Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

Timeframe: Up to 19 Months

Trial details

NCT IDNCT02438813

SponsorKythera Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-11-10

Results submitted2017-11-14

View on ClinicalTrials.gov More Submental Fullness trials

Who can participate

Age range

18 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.