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
First published:
10/12/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Anita Verga

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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