Evoke Radiofrequency Device for Improvement of Skin Appearance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04050033|
Recruitment Status : Completed
First Posted : August 8, 2019
Last Update Posted : January 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Improvement of Skin Appearance||Device: Evoke Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Evaluate the Performance of Evoke Radiofrequency Device for Improvement of Skin Appearance|
|Actual Study Start Date :||June 19, 2019|
|Actual Primary Completion Date :||December 30, 2021|
|Actual Study Completion Date :||December 30, 2021|
Experimental: Treatment Arm
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and Tx.3).
Device: Evoke Device
Subjects will undergo treatment with Evoke Device
- Number of participants with Change in Skin Appearance [ Time Frame: 1 month, 3 month, 6 months ]Picture evaluation by blinded investigators.
- Evaluate rate of Change in Skin Appearance using 3D Photographic analysis [ Time Frame: 1 month, 3 month, 6 months ]3D Photographic analysis will be conducted using QuantifiCare System
- Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software [ Time Frame: 1 month, 3 month, 6 months ]Non-invasive in vivo skin imaging will be taken with the VivoSight Optical Coherence Tomography (OCT).
- Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers. [ Time Frame: 1 month, 3 month, 6 months ]The pictures will be sent through the system and evaluated by crowd workers.
- Evaluate Investigator assessment of the skin appearance improvement [ Time Frame: 1 Month, 3 Months, 6 Months ]
Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 1 month, 3 months and 6 months follow up visits:
• 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference
- Evaluate Subject assessment of improvement and satisfaction [ Time Frame: 1 Month, 3 Months, 6 Months ]
Improvement assessment will be performed independently by the subject himself 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as follows:
• 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference.
Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as follows:
• +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed.
- Evaluate histological changes to treatment area skin [ Time Frame: 3 Months ]Positive changes in histologic evaluation: up to 5 subjects will undergo biopsies of the treated area for histology at baseline and at 3M follow-up visit. Histological sections will be stained using elastin, H&E and other collagen specific stains.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050033
|United States, Nevada|
|Avance Plastic Surgery Institute|
|Reno, Nevada, United States, 89511|
|United States, New York|
|Union Square Laser Dermatology|
|New York, New York, United States, 10003|
|New York, New York, United States, 10019|
|Principal Investigator:||Erez Dayan, MD||Avance Plastic Surgery Institute 5570 Longley Lane, Suite A Reno, NV 89511|
|Principal Investigator:||Christopher Chia, MD||BodySculpt 128 Central Park S New York, NY 10019|