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

Study identification

• EU PAS number:
  EUPAS16159
• Study ID:
  22717
• Official title and acronym:
  CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  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 Study Design This is a prospective, observational, multi-center registry. Enrolled patients will provide information related to the condition and treatments of interest and will permit their physicians to provide any available data concerning their condition status and treatment Treatment Procedures The eligibility of patients for treatment, and the treatment administered, will be determined by the physician Patient Population 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 Sample Size Approximately 1000 patients will be recruited from approximately 100 sites in the US and Canada Study Procedures Eligible patients will be enrolled in the registry and data will be collected from patients who elect treatment until their SMF reduction treatment is completed or discontinued. At enrollment, data on previous relevant SMF and facial aesthetic treatment(s) will be collected from the patients, and as necessary, their medical records, along with baseline SMF assessments and information on treatment goals Duration Data collection is anticipated to continue for approximately 15 months Data Collection EDC will be used to collect study related data. Data on Baseline information, treated related events, adverse events during follow-up and treatment outcomes will be collected Analysis Analyses will be based upon all patients who were enrolled and have at least one post-baseline visit. Data will be summarized, by type of SMF reduction treatment, with descriptive statistics, and presented in listings
• Study status:
  Finalised

Research institutions and networks

Institutions

Parexel International

United States

Study timelines

Date when funding contract was signed

Planned: 20/10/2014

Actual: 30/12/2014

Study start date

Planned: 12/05/2015

Actual: 12/05/2015

Date of final study report

Planned: 30/06/2016

Actual: 26/10/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

ATX-101-15-40M