Trial Outcomes & Findings for Condition of Submental Fullness and Treatment Outcomes Registry (NCT NCT02438813)

Last Updated: 2018-10-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1029 participants

Primary outcome timeframe

Up to 19 Months

Results posted on

2018-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1029
Overall Study Received Treatment for SMF	676
Overall Study Did Not ReceiveTreatment for SMF	353
Overall Study COMPLETED	504
Overall Study NOT COMPLETED	525

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Patient Decision	59
Overall Study Patient Lost to Follow-Up	137
Overall Study Study Ended by Sponsor	80
Overall Study Patients Not Treated/No EOT Visit	249

Baseline Characteristics

Condition of Submental Fullness and Treatment Outcomes Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Participants n=1029 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.
Age, Continuous	49.9 years STANDARD_DEVIATION 12.30 • n=5 Participants
Age, Customized 18 to 30 years	81 participants n=5 Participants
Age, Customized 31 to 50 years	427 participants n=5 Participants
Age, Customized 51 to 65 years	413 participants n=5 Participants
Age, Customized >65 years	108 participants n=5 Participants
Sex: Female, Male Female	883 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 19 Months

Population: Safety Population included all participants who received at least one treatment. Participants may have received more than one treatment.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid (ATX-101) n=570 Participants Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.	Surgical n=23 Participants Surgical procedures for the treatment of SMF as per standard of care in clinical practice.	Laser Liposuction n=5 Participants Laser Liposuction for treatment of SMF as per standard of care in clinical practice.	Energy Devices n=77 Participants Energy Devices as treatment for SMF as per standard of care in clinical practice.	Other Treatments n=9 Participants Other Treatments for treatment of SMF as per standard of care in clinical practice.	Not Elected Treatment All enrolled participants who did not elect to have treatment for SMF.
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	13.2 percentage of participants	8.7 percentage of participants	20.0 percentage of participants	5.2 percentage of participants	22.2 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months)

Population: Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.

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.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid (ATX-101) n=570 Participants Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.	Surgical n=23 Participants Surgical procedures for the treatment of SMF as per standard of care in clinical practice.	Laser Liposuction n=5 Participants Laser Liposuction for treatment of SMF as per standard of care in clinical practice.	Energy Devices n=77 Participants Energy Devices as treatment for SMF as per standard of care in clinical practice.	Other Treatments n=9 Participants Other Treatments for treatment of SMF as per standard of care in clinical practice.	Not Elected Treatment n=676 Participants All enrolled participants who did not elect to have treatment for SMF.
Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Change to EOT Visit	-0.8 score on a scale Standard Deviation 0.8	-2.1 score on a scale Standard Deviation 1.0	-2.5 score on a scale Standard Deviation 0.7	-0.9 score on a scale Standard Deviation 1.0	-0.2 score on a scale Standard Deviation 0.5	-0.8 score on a scale Standard Deviation 0.9
Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Baseline	2.0 score on a scale Standard Deviation 0.8	2.7 score on a scale Standard Deviation 0.8	3.2 score on a scale Standard Deviation 0.8	1.7 score on a scale Standard Deviation 0.8	1.8 score on a scale Standard Deviation 1.1	2.0 score on a scale Standard Deviation 0.8
Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Change to Follow-up Visit	-0.4 score on a scale Standard Deviation 0.7	-1.6 score on a scale Standard Deviation 1.1	-2.0 score on a scale Standard Deviation 1.0	-0.7 score on a scale Standard Deviation 0.7	-0.4 score on a scale Standard Deviation 0.6	-0.5 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid (ATX-101) n=570 Participants Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.	Surgical n=23 Participants Surgical procedures for the treatment of SMF as per standard of care in clinical practice.	Laser Liposuction n=5 Participants Laser Liposuction for treatment of SMF as per standard of care in clinical practice.	Energy Devices n=77 Participants Energy Devices as treatment for SMF as per standard of care in clinical practice.	Other Treatments n=9 Participants Other Treatments for treatment of SMF as per standard of care in clinical practice.	Not Elected Treatment n=676 Participants All enrolled participants who did not elect to have treatment for SMF.
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Baseline	2.0 score on a scale Standard Deviation 0.7	2.5 score on a scale Standard Deviation 0.7	3.2 score on a scale Standard Deviation 0.8	1.8 score on a scale Standard Deviation 0.7	2.0 score on a scale Standard Deviation 0.9	2.0 score on a scale Standard Deviation 0.7
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Change to Follow-up Visit	-0.3 score on a scale Standard Deviation 0.7	-1.5 score on a scale Standard Deviation 0.9	-2.2 score on a scale Standard Deviation 1.1	-0.5 score on a scale Standard Deviation 0.8	-0.8 score on a scale Standard Deviation 0.8	-0.4 score on a scale Standard Deviation 0.8
Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Change to EOT Visit	-0.7 score on a scale Standard Deviation 0.8	-1.6 score on a scale Standard Deviation 0.9	-2.0 score on a scale Standard Deviation 0.0	-0.8 score on a scale Standard Deviation 0.9	-0.5 score on a scale Standard Deviation 0.6	-0.7 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid (ATX-101) n=570 Participants Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.	Surgical n=23 Participants Surgical procedures for the treatment of SMF as per standard of care in clinical practice.	Laser Liposuction n=5 Participants Laser Liposuction for treatment of SMF as per standard of care in clinical practice.	Energy Devices n=77 Participants Energy Devices as treatment for SMF as per standard of care in clinical practice.	Other Treatments n=9 Participants Other Treatments for treatment of SMF as per standard of care in clinical practice.	Not Elected Treatment n=676 Participants All enrolled participants who did not elect to have treatment for SMF.
Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) Baseline	6.9 score on a scale Standard Deviation 1.8	7.9 score on a scale Standard Deviation 1.5	9.0 score on a scale Standard Deviation 0.0	6.2 score on a scale Standard Deviation 2.2	7.0 score on a scale Standard Deviation 2.4	6.9 score on a scale Standard Deviation 1.9
Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) Change to Follow-up Visit	-1.2 score on a scale Standard Deviation 1.9	-4.6 score on a scale Standard Deviation 2.3	-6.6 score on a scale Standard Deviation 2.7	-1.8 score on a scale Standard Deviation 2.4	-2.4 score on a scale Standard Deviation 2.1	-1.5 score on a scale Standard Deviation 2.2
Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) Change to EOT Visit	-2.8 score on a scale Standard Deviation 2.6	-5.4 score on a scale Standard Deviation 2.6	-6.5 score on a scale Standard Deviation 2.1	-2.4 score on a scale Standard Deviation 2.7	-2.3 score on a scale Standard Deviation 1.3	-2.9 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid (ATX-101) n=570 Participants Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.	Surgical n=23 Participants Surgical procedures for the treatment of SMF as per standard of care in clinical practice.	Laser Liposuction n=5 Participants Laser Liposuction for treatment of SMF as per standard of care in clinical practice.	Energy Devices n=77 Participants Energy Devices as treatment for SMF as per standard of care in clinical practice.	Other Treatments n=9 Participants Other Treatments for treatment of SMF as per standard of care in clinical practice.	Not Elected Treatment n=676 Participants All enrolled participants who did not elect to have treatment for SMF.
Change From Baseline in the Subject Self Rating Scale (SSRS) Baseline	2.3 score on a scale Standard Deviation 1.4	2.0 score on a scale Standard Deviation 1.6	1.4 score on a scale Standard Deviation 1.5	2.1 score on a scale Standard Deviation 1.4	2.6 score on a scale Standard Deviation 1.2	2.2 score on a scale Standard Deviation 1.4
Change From Baseline in the Subject Self Rating Scale (SSRS) Change to Follow-up Visit	1.0 score on a scale Standard Deviation 1.7	2.4 score on a scale Standard Deviation 1.9	3.6 score on a scale Standard Deviation 2.1	1.6 score on a scale Standard Deviation 1.8	1.2 score on a scale Standard Deviation 2.2	1.1 score on a scale Standard Deviation 1.8
Change From Baseline in the Subject Self Rating Scale (SSRS) Change to EOT	2.0 score on a scale Standard Deviation 2.0	2.8 score on a scale Standard Deviation 2.3	4.5 score on a scale Standard Deviation 2.1	2.1 score on a scale Standard Deviation 1.9	1.3 score on a scale Standard Deviation 1.5	2.1 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Deoxycholic Acid (ATX-101) n=570 Participants Deoxycholic acid injection (ATX-101) as treatment for SMF as per standard of care.	Surgical n=23 Participants Surgical procedures for the treatment of SMF as per standard of care in clinical practice.	Laser Liposuction n=5 Participants Laser Liposuction for treatment of SMF as per standard of care in clinical practice.	Energy Devices n=77 Participants Energy Devices as treatment for SMF as per standard of care in clinical practice.	Other Treatments n=9 Participants Other Treatments for treatment of SMF as per standard of care in clinical practice.	Not Elected Treatment n=676 Participants All enrolled participants who did not elect to have treatment for SMF.
Change From Baseline in the Patient Self-Perception of Age (SPA) Baseline	-1.4 years Standard Deviation 5.0	0.5 years Standard Deviation 4.3	3.0 years Standard Deviation 6.7	-0.5 years Standard Deviation 4.1	-0.6 years Standard Deviation 3.2	-1.2 years Standard Deviation 4.9
Change From Baseline in the Patient Self-Perception of Age (SPA) Change to EOT Visit	-1.5 years Standard Deviation 5.3	-5.6 years Standard Deviation 6.2	-10.0 years Standard Deviation 0.0	-0.6 years Standard Deviation 3.1	-0.8 years Standard Deviation 4.4	-1.6 years Standard Deviation 5.3

SECONDARY outcome

Timeframe: 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.