CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Belkyra

Population studied

• Short description of the study population:
  Adult male and female patients, aged 18 years and above, presenting with submental (SM) fullness due to the accumulation of unwanted submental fat (SMF), and considered by their treating physician to be a candidate to receive treatment of SM fullness by reduction of SMF.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  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.
• Data analysis plan:
  Results for SMF assessments will be summarized with descriptive statistics at each time point. Changes from baseline will be summarized descriptively for each treatment cohort at each post-baseline assessment. Exploratory analysis of covariance (ANCOVA) methods will also be used to assess change from baseline at the end-of-treatment follow-up time point, where treatment type and baseline score will be included in the model. AE and AE mitigation data will be summarized with descriptive statistics, by type of SMF reduction treatment, system organ class (SOC), and preferred term (PT), and presented in listings. The duration (days) and severity of pain, swelling, and bruising will be summarized by type of SMF reduction treatment, by treatment session, and overall. Pain scores from the Pain Numeric Rating Scale will be summarized with descriptive statistics by type of SMF reduction treatment and time point.