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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04050033|
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Improvement of Skin Appearance||Device: Evoke Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 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|
|Estimated Primary Completion Date :||July 19, 2020|
|Estimated Study Completion Date :||August 19, 2020|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050033
|Contact: Maureen Abdullaemail@example.com|
|Contact: Maria Shustermanfirstname.lastname@example.org|
|United States, Nevada|
|Avance Plastic Surgery Institute||Recruiting|
|Reno, Nevada, United States, 89511|
|Contact: Erez Dayan, MD 775-800-4444|
|United States, New York|
|New York, New York, United States, 10019|
|Contact: Christopher Chia, MD 212-265-2724|
|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|