Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565884
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Study on the Safety Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital WrinklesF-MFR300-RD-003
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Rate-blind Multicenter Optimity-designed Clinical Trial Evaluating the Safety and Efficacy of RFskin Therapy Devices for the Reduction of Skin Wrinkles
Status:
COMPLETED
Status Verified Date:
2024-08
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:
This is a multicenter trial with randomized control and evaluator blind method which meets the screening criteria total of 224 subjects were enrolled and randomly divided into control group and experiment according to 11 ratio Group the subjects in the control group used medical ultrasonic coupler and the subjects in the test group used test instruments Combined with medical ultrasonic coupler use 5 days per week according to the prescribed use method durationUse the whole face for 10 minutes use twice a day a total of 20 minutes continuous use 12Week The changes of relevant clinical indicators and laboratory instrument measurements were evaluated
Objective To evaluate the efficacy of radiofRF in reducing skin wrinkles and treating loose skin after 12 weeks of use of the test product Effectiveness and safety of relaxation and firming of skin tissue
The subjects were adults aged 18 years and above regardless of gender and had obvious wrinkles on the skin around the face and eyes according to the selection Standard confirmation
Objective To evaluate the efficacy of radiofRF in reducing skin wrinkles and treating loose skin after 12 weeks of use of the test product Effectiveness and safety of relaxation and firming of skin tissue
The subjects were adults aged 18 years and above regardless of gender and had obvious wrinkles on the skin around the face and eyes according to the selection Standard confirmation
Detailed Description:
The purpose of the clinical trial was to see if home radiofrequency beauty devices were effective in treating adults for reducing skin wrinkles It will also learn about the safety of home RF beauty devices The main questions it aims to answer are
1 Reduction of facial or periocular wrinkles based on Fitzpatrick score 12 weeks
2 Possible adverse reactions and satisfaction survey during the use of subjects The researchers will compare the radiofrequency beauty device group with the control group only medical ultrasonic coupling to verify whether the home radiofrequency beauty device is effective in reducing skin wrinkles
Participants will
Receive home treatment according to the experimental group and continue to use it for 12 weeks
At the 6th and 12th week they will visit the medical institution for questionnaire survey and skin test
Keep a diary of their symptoms and the number of times they use radiofrequency beauty device or medical ultrasonic coupling
1 Reduction of facial or periocular wrinkles based on Fitzpatrick score 12 weeks
2 Possible adverse reactions and satisfaction survey during the use of subjects The researchers will compare the radiofrequency beauty device group with the control group only medical ultrasonic coupling to verify whether the home radiofrequency beauty device is effective in reducing skin wrinkles
Participants will
Receive home treatment according to the experimental group and continue to use it for 12 weeks
At the 6th and 12th week they will visit the medical institution for questionnaire survey and skin test
Keep a diary of their symptoms and the number of times they use radiofrequency beauty device or medical ultrasonic coupling
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