Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

Kythera Biopharmaceuticals

Status: Completed

Conditions: Submental Fullness

Treatments: Procedure: Surgical Procedures; Other: Other Treatments; Device: Energy Devices; Procedure: Laser Liposuction; Drug: Deoxycholic acid

Study type: Observational

Funder types: Industry

Identifiers

NCT02438813

CONTOUR

Details and patient eligibility

About

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.

Enrollment: 1,029 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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, if the patient decides
• Signed informed consent by the patient, obtained before any study-related activities are undertaken
• Willing to complete all patient assessment questionnaires
• Signed release form by the patient, permitting abstraction of the patient's medical records at baseline and during participation in the registry

Exclusion criteria

• 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
• Any other cause of fullness in the SM area (eg, thyroid enlargement, cervical adenopathy) other than localized SMF
• Participating in an interventional clinical study, currently or within 30 days before enrollment

Trial design

1,029 participants in 1 patient group

All Enrolled Participants

Description:

All enrolled participants who signed informed consent whether or not they elected to receive treatment as per standard of care in clinical practice for submental fat (SMF). Treatments for SMF included: ATX1-101, Surgical Procedures, Laser Liposuction, Energy Devices or Other Treatments.

Treatment:

Drug: Deoxycholic acid

Procedure: Surgical Procedures

Other: Other Treatments

Device: Energy Devices

Procedure: Laser Liposuction