Submental FullnessNCT03691415
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
An observational study of Submental Fullness, run by Allergan at 4 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Submental Fullness
- What is being tested?
- BELKYRA Inj.
- How many people
- 71 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 7 Sep 2018to 14 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patient is an adult (≥ 18 years of age) in South Korea treated with BELKYRA for the improvement of moderate to severe convexity or fullness associated with submental fat in adults
Who may be able to join
- Eligible and consenting Korean patients
- Patients who have consented to the study and who have signed the private information protection act form or ICF
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Oracle-Dermatology
Daejeon, 35234
Goldenview plastic surgery
Seoul, 06010
(Apgujeong) Oracle-Dermatology
Seoul, 06022
Dream-Dermatology
Seoul, 06030
About this study
Official title: Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Post Marketing Surveillance Study in Korea
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
- Conditions
- Submental Fullness
- Being tested
- BELKYRA Inj.
- Keywords
- Double Chin Fat Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BELKYRA Inj.Drug
Also called Deoxycholic acid
Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart.
| Study group | Role | What they receive |
|---|---|---|
| BELKYRA Inj. | Each patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart and follow-up within 3 months of the last treatment session. Receives: Drug: BELKYRA Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
A validated scale used by investigators to assess SM convexity/amount of SMF. Specifically, the CR-SMFRS ranges in whole number increments from 0 (absent submental convexity) to 4 (extreme submental convexity)
Measured: Baseline, Follow up visit (within 3 months of injection)
Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Validated scale used by patients to evaluate SM size. Specifically, the PR-SMFRS asks patients to assess how much fat they have under their chins by selecting options ranging from "no chin fat at all" to "a very large amount of chin fat".
Measured: Baseline, Follow up visit (within 3 months of injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start7 Sep 2018
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Why it stopped: Study discontinued due to business decisions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submental FullnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne St. Rose, DVM, MSc, PhD, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691415
- Sponsor's protocol ID
- CMO-EPI-FAS-0537
- Other IDs
- EUPAS23762
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2018
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Post Marketing Surveillance Study in Korea
- ClinicalTrials.gov ID
- NCT03691415
- Acronym / sponsor ID
- CMO-EPI-FAS-0537
- Conditions
- Submental Fullness
- Keywords
- Double Chin Fat Reduction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study discontinued due to business decisions.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BELKYRA Inj. | – | Drug: BELKYRA Inj.Each patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart and follow-up within 3 months of the last treatment session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patient is an adult (≥ 18 years of age) in South Korea treated with BELKYRA for the improvement of moderate to severe convexity or fullness associated with submental fat in adults
Key inclusion criteria (2 listed)
- Eligible and consenting Korean patients
- Patients who have consented to the study and who have signed the private information protection act form or ICF
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BELKYRA Inj.Also: Deoxycholic acidPatient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart. | Drug | BELKYRA Inj. |
Primary outcome
Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time frame: Baseline, Follow up visit (within 3 months of injection)
A validated scale used by investigators to assess SM convexity/amount of SMF. Specifically, the CR-SMFRS ranges in whole number increments from 0 (absent submental convexity) to 4 (extreme submental convexity)
Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline, Follow up visit (within 3 months of injection)
Validated scale used by patients to evaluate SM size. Specifically, the PR-SMFRS asks patients to assess how much fat they have under their chins by selecting options ranging from "no chin fat at all" to "a very large amount of chin fat".
Results and safety
The study was stopped early (reason given: Study discontinued due to business decisions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance."Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne St. Rose, DVM, MSc, PhD study director
Allergan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Submental Fullness, run by Allergan at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study discontinued due to business decisions.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (time frame: Baseline, Follow up visit (within 3 months of injection)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.