Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Phase 4, prospective, observational, multi-center registry
Study drug and medical condition

Name of medicine, other

Belkyra
Population studied

Short description of the study population

Patients considering treatment to reduce submental fat (SMF) and who plan to pursue treatment with Belkyra™ will be recruited. Eligible patients will be enrolled in the registry, and patients who elect treatment with Belkyra™ will be followed until their SMF reduction treatment is completed or discontinued.
Patients must have met all of the following criteria for inclusion in the study:
Inclusion Criteria:
1.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 SMF reduction treatment with Belkyra™.
2.Patient had confirmed plans with their treating physician to receive treatment with Belkyra™.
3.Signed informed consent by the patient, obtained before any study-related activities were undertaken.
4.Willing to complete all patient assessment questionnaires.
5.Signed release form by the patient, permitting abstraction of the patient’s medical records at baseline and during participation in the registry.
Exclusion Criteria:
1.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.
2.Any other cause of fullness in the SM area (e.g., thyroid enlargement, thyromegaly, cervical adenopathy, cervical lymphadenopathy, pronounced submandibular glands, lymph nodes, and muscles) other than localized SMF.
3.Participating in an interventional clinical study, currently or within 30 days before enrolment.
4.Participated previously in an interventional clinical study involving Belkyra™

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

100
Study design details

Main study objective

The primary objective of this registry is to develop a comprehensive understanding of how Belkyra is utilized in clinical practice in Australia, following its approval for the treatment of submental fullness due to submental fat,

Data analysis plan

Data will be summarized with descriptive statistics, and presented in listings. Demographic and baseline characteristics will be summarized. Post-baseline values and change from baseline in selected outcome variables will be summarized with descriptive statistics, and, where appropriate, graphical presentations, and presented in listings. All statistical tests will be tested on two-sided significance level of 0.05 and will be considered exploratory.