Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657365
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of the Facial Wrinkles a Prospective Multicenter Evaluator Blinded Randomized Parallel-controlled Non-inferior Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc for improving facial and periorbital wrinkles This is a prospective multicenter evaluator-blinded randomized parallel-controlled non-inferiority clinical trial
The main questions the study aims to answer are
Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles Is the safety profile of the monopolar radiofrequency device acceptable
Researchers will compare the investigational device to the Thermage CPT System Solta Medical Co Ltd to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement
Participants will
Undergo a single treatment session with either the investigational device or the control device
Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes
The primary outcome will be the improvement in facial and periorbital wrinkles measured by the Facial Wrinkle and Elasticity Scale FWES 3 months post-treatment Secondary outcomes include the Global Aesthetic Improvement Scale GAIS and a Visual Analog Scale VAS for pain Safety evaluations will include adverse event AE and serious adverse event SAE monitoring
The main questions the study aims to answer are
Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles Is the safety profile of the monopolar radiofrequency device acceptable
Researchers will compare the investigational device to the Thermage CPT System Solta Medical Co Ltd to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement
Participants will
Undergo a single treatment session with either the investigational device or the control device
Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes
The primary outcome will be the improvement in facial and periorbital wrinkles measured by the Facial Wrinkle and Elasticity Scale FWES 3 months post-treatment Secondary outcomes include the Global Aesthetic Improvement Scale GAIS and a Visual Analog Scale VAS for pain Safety evaluations will include adverse event AE and serious adverse event SAE monitoring
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None