Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Su… (NCT03691415) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Postmarketing Surveillance Study in Korea
Stopped: Study discontinued due to business decisions.
South Korea71 participantsStarted 2018-09-07
Plain-language summary
The purpose of this PMS study is to evaluate the safety and effectiveness of BELKYRA Inj. used according to the dose specified in the instructions for use, for the treatment of patients with SM fullness due to SMF, through active investigation under routine clinical practice
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:
* Eligible and consenting Korean patients
* Patients who have consented to the study and who have signed the private information protection act form or ICF
Exclusion Criteria:
* Patients having infection at the infection sites
* Patients presenting evidence of causes of enlarged submental area other than localized submental fat (E.g.: thyroid enlargement, enlarged submental salivary glands, cervical lymphadenopathy, etc.)
* Patients participating in an interventional clinical study, currently or within 30 days before enrollment, will not be eligible for inclusion in the study
* Pregnant women
* Renal impairment patients
* Hepatic impairment patients
* Patients with severe laxity
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
1
Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Timeframe: Baseline, Follow up visit (within 3 months of injection)
2
Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Timeframe: Baseline, Follow up visit (within 3 months of injection)