Trial Outcomes & Findings for Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance (NCT NCT04721600)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

6 months

Results posted on

2024-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Evoke Radiofrequency Device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=15 Participants Evoke Radiofrequency Device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
Age, Continuous	58 years STANDARD_DEVIATION 9.05 • n=15 Participants
Sex: Female, Male Female	15 Participants n=15 Participants
Sex: Female, Male Male	0 Participants n=15 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Treatment n=9 Participants Evoke Radiofrequency Device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
Percentage of Participants With Baseline and 6 Month Face Photographs Correctly Identified by Two Blind Evaluators	7 Participants

SECONDARY outcome

Timeframe: month 6

Population: level of the patients' improvement at 6 months post-treatment. Investigators utilized a scale anchored by 0 (no difference) and 4 (significantly marked improvement).

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

Outcome measures

Outcome measures
Measure	Treatment n=7 Participants Evoke Radiofrequency Device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
Investigator Assessment of the Skin Appearance	2.4 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: month 6

Population: 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).

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

Outcome measures
Measure	Treatment n=12 Participants Evoke Radiofrequency Device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
Subject Assessment of Change and Satisfaction With the Procedure	0.18 units on a scale Interval -2.0 to 2.0

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=15 participants at risk Evoke Radiofrequency Device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
Skin and subcutaneous tissue disorders persistent erythema	6.7% 1/15 • Number of events 1 • 6 months

Additional Information

Maria Shusterman

Inmode

Phone: 9057076787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place