NCT04721600

Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance

Completed NA Results posted Last updated 11 June 2024

What this trial tests

NA trial testing Evoke Radiofrequency Device in Skin Laxity in 15 participants. Completed in 28 July 2022.

Timeline

1 November 2020

Primary endpoint
28 July 2022

28 July 2022

Quick facts

Lead sponsor	InMode MD Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	15
Start date	1 November 2020
Primary completion	28 July 2022
Estimated completion	28 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Evoke Radiofrequency Device

Conditions studied

• Skin Laxity — all drugs for Skin Laxity →

Sponsor

InMode MD Ltd.

Who can join

Adults 35 to 75, any sex, with Skin Laxity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Baseline and 6 Month Face Photographs Correctly Identified by Two Blind Evaluators Primary · 6 months

Group	Value	95% CI
Treatment	7

Investigator Assessment of the Skin Appearance Secondary · month 6

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

Group	Value	95% CI
Treatment	2.4	0 – 4

Subject Assessment of Change and Satisfaction With the Procedure Secondary · month 6

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).

Group	Value	95% CI
Treatment	0.18	-2 – 2

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment
persistent erythema	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04721600 adverse events section.

Sponsor's own description

Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance.
   Labadie JG, Chilukuri S, Cohen J, Kilmer S, et al · · 2023 · cited 7× · PMID 36533797 · DOI 10.1097/dss.0000000000003666