Condition of Submental Fullness and Treatment Outcomes Registry

Completed

Conditions: Submental Fullness

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

Registration Number: NCT02438813

Lead Sponsor: Kythera Biopharmaceuticals

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1029

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Enrolled Participants	Deoxycholic acid	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.
All Enrolled Participants	Laser Liposuction	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.
All Enrolled Participants	Energy Devices	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.
All Enrolled Participants	Surgical Procedures	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.
All Enrolled Participants	Other Treatments	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	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 Outcome Measures

Name	Time	Method
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)	The CR-SMFRS is based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. A negative change from Baseline indicates improvement.
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)	The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0 to 4) with 0=No chin fat at all, 1=A slight amount of chin fat, 2=A moderate amount of chin fat, 3=A large amount of chin fat, and 4=A very large amount of chin fat. A negative change from Baseline indicates improvement.
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)	The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.
Change From Baseline in the Patient Self-Perception of Age (SPA)	Baseline (Day 1) to End of Treatment Visit (Up to 18 Months)	The participant rated their facial age in years at Baseline and at the End of Treatment Visit by answering the question: How many years difference compare to your actual age? A negative number indicates younger and a positive number indicates older. A negative change from Baseline indicates an improvement.
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)	SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy \[no skin draping or skin sagging\]; Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy \[slight skin draping and sagging\]; Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy \[moderate skin draping and skin sagging\]; Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy \[marked skin draping and sagging\]. A negative change from Baseline indicates improvement.
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)	The participant was asked to answer the question: "Considering your appearance in association with your face and chin, how satisfied do you feel with your appearance at the present time?" using a 7-point scale: 0=Extremely dissatisfied, 1=Dissatisfied, 2=Slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=Slightly satisfied, 5=Satisfied, and 6=Extremely satisfied. A positive change from Baseline indicates improvement.

Trial Locations

Locations (95): Skin Spectrum LLC
🇺🇸
Tucson, Arizona, United States
John Joseph, MD
🇺🇸
Beverly Hills, California, United States
The Roxbury Institute
🇺🇸
Beverly Hills, California, United States
Brian M Kinney, MD Inc
🇺🇸
Beverly Hills, California, United States
Bella Skin Institute
🇺🇸
Calabasas, California, United States
Jerome R Potozkin MD
🇺🇸
Danville, California, United States
Kathleen L Behr
🇺🇸
Fresno, California, United States
Ocdermatology Lorrie Klein
🇺🇸
Laguna Niguel, California, United States
Westside Aesthetics
🇺🇸
Los Angeles, California, United States
Skin Care and Laser Physicians of Beverly Hills
🇺🇸
Los Angeles, California, United States
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Skin Spectrum LLC
🇺🇸Tucson, Arizona, United States