Trial Outcomes & Findings for Treatment With the Evoke System for Facial and Submental Laxity (NCT NCT04719013)

NCT ID: NCT04719013

Last Updated: 2023-03-31

Results Overview

Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 85 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2023-03-31

Participant Flow

Participant milestones

Measure	Treatment Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Overall Study STARTED	85
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment n=85 Participants Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Age, Continuous	53.49 years n=85 Participants
Sex: Female, Male Female	82 Participants n=85 Participants
Sex: Female, Male Male	3 Participants n=85 Participants

PRIMARY outcome

Timeframe: Month 6

Population: 2 of 3 blind evaluators would agree on skin appearance based on photographs for 70% of patients

Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators)

Outcome measures

Measure	Treatment n=85 Participants Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Evaluate Change in Skin Appearance	80.7 percentage of participants

SECONDARY outcome

Timeframe: month 6

Population: Investigator assessment of the skin appearance improvement comparing pre and post-treatment using 0 - 4 -points Likert scale at 6 months follow-up visits.

Evaluate Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 6 months follow up visits. 0-no change, 1- mild improvement, 2- moderate improvement, 3- marked improvement, 4- significantly marked improvement

Outcome measures

Measure	Treatment n=85 Participants Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Evaluate Investigator Assessment of the Skin Appearance	1 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: month 6

Population: Patients assessed the level of their skin appearance improvement at 6 months post-treatment. Patients utilized a scale anchored by 0 (no difference) and 4 (significantly marked improvement)

Evaluate Subject assessment of improvement and satisfaction using 0 - 4 -points Likert scale at 6 months follow up visits, Improvement: 0-no change, 1- mild improvement, 2- moderate improvement, 3-marked improvement, 4- significantly marked improvement.

Outcome measures

Measure	Treatment n=85 Participants Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Evaluate Subject Assessment of Improvement and Satisfaction	1 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: month 6

Finally, patients assessed their satisfaction with the procedure at 6 months post-treatment. Patients utilized a scale anchored by -2 (very disappointed) and 2 (very satisfied).

Outcome measures

Measure	Treatment n=85 Participants Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Patient Satisfaction With the Procedure	0.62 score on a scale Interval -2.0 to 2.0

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=85 participants at risk Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Skin and subcutaneous tissue disorders burn	2.4% 2/85 • Number of events 2 • 6 months
Skin and subcutaneous tissue disorders hypopigmentation	1.2% 1/85 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders mild tenderness	1.2% 1/85 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders blister	1.2% 1/85 • Number of events 1 • 6 months

Additional Information

Maria Shusterman

InMode

Phone: 9057076787

Email: Maria.Shusterman@inmodemd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place