CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and Associated Outcomes)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,029
- Locations
- 95
- Primary Endpoint
- Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Study Overview
Brief Summary
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
All Enrolled Participants
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.
Intervention: Deoxycholic acid (Drug)
All Enrolled Participants
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.
Intervention: Surgical Procedures (Procedure)
All Enrolled Participants
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.
Intervention: Laser Liposuction (Procedure)
All Enrolled Participants
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.
Intervention: Energy Devices (Device)
All Enrolled Participants
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.
Intervention: Other Treatments (Other)
Outcomes
Primary Outcomes
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to 19 Months
An adverse event is any undesirable medical occurrence or worsening of an existing condition that occurs after SMF reduction treatment, irrespective of whether the event is considered treatment related. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving treatment.
Secondary Outcomes
- Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)(Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months))
- Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)(Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months))
- Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS)(Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months))
- Change From Baseline in the Patient Self-Perception of Age (SPA)(Baseline (Day 1) to End of Treatment Visit (Up to 18 Months))
- Change From Baseline in the Submental Skin Laxity Scale (SMSLG)(Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months))
- Change From Baseline in the Subject Self Rating Scale (SSRS)(Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months))