Skin WrinklesYM-1NCT06441799
Study on the Safety, Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital Wrinkles
A study testing Home radiofrequency skin treatment instrument and Ultrasonic coupler for medical purposes in people with Skin Wrinkles, run by Glomed(HN)Co.Ltd at 1 site in China.
Trial 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 1:1 ratio Group), the subjects in the control group used medical ultrasonic coupler, and the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Wrinkles
- What is being tested?
- Home radiofrequency skin treatment instrument and Ultrasonic coupler for medical purposes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 29 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) Adults aged 18 and above, male or female;
- (2) Fitzpatrick's wrinkles and elasticity scores around the face and eyes were 2-7 points (on-site assessment);
- (3) To avoid sun exposure during the test;
- (4) Be able to read Chinese and accurately understand, and sign the informed consent of the test;
- (5) can cooperate with and participate in the test return visit time, and timely reflect their own health status or any changes in drugs, adverse reaction symptoms;
- (6) Urine pregnancy reaction is negative (women of childbearing age).
Who cannot join
- (1) Abnormal vital signs (blood pressure, pulse, body temperature), except for minor abnormalities that are not clinically significant as determined by the doctor;
- (2) There is a pacemaker or internal defibrillator in the body, or any other active electrical implant anywhere in the body;
- (3) The treatment area has permanent implants, such as metal plates and screws (e.g. dentures, metal teeth), silicone implants or injected chemicals;
- (4) There is or has been a history of skin cancer, or any other type of cancer, or malignant pre-nevus;
- (5) serious comorbidities, such as heart disease, epilepsy, high blood pressure and liver or kidney disease;
- (6) Plan to become pregnant or breastfeed during the study period, or less than 6 months after delivery;
Show all 22Show fewer
- (7) Have a history of bleeding and clotting, or long-term use of anticoagulation and antiplatelet drugs (aspirin ≤81mg daily is not excluded);
- (8) Suffering from autoimmune diseases;
- (9) have an immunosuppressive disease such as AIDS, or an impaired immune system caused by the use of immunosuppressive drugs (investigators' judgment);
- (10) Subjects with a history of heat-stimulated disease, such as recurrent herpes simplex in the treatment area, should only be treated after a pre-prevention regimen;
- (11) Poor control of diseases related to the endocrine system as determined by the investigator, such as diabetes or thyroid dysfunction;
- (12) Any active condition in the treatment area identified by the investigator, such as ulcers, eczema, or other skin lesions;
- (13) A history of skin diseases, such as keloid, abnormal wound healing, psoriasis, etc.;
- (14) Any invasive or non-invasive treatment (such as hair removal, light rejuvenation, microneedles or chemical exfoliation, etc.) in the treated area within 3 months prior to treatment;
- (15) Received RF microneedle therapy, injection of fillers or botulinum toxin within 6 months prior to treatment;
- (16) Receive semi-permanent fillers (poly-l-lactic acid, calci-hydroxy-phospholite, etc.) within 24 months before treatment;
- (17) Have undergone facial medical or cosmetic surgery (e.g. eyelid/eyebrow surgery, periorbital or perioral soft tissue enhancement, permanent fillers, permanent makeup, tattoos, etc.);
- (18) Use of drugs that may trigger photosensitization during the study period (such as quinolones, aspirin, hyd rochlorothiazide or furosemide);
- (19) Use of any medications that affect skin characteristics (e.g., vitamin A, steroids, thyroid medications, etc.) in the past 6 months;
- (20) Participate in a clinical trial of another drug or device in which the last treatment of the investigational drug/device occurred 3 months before the start of treatment in the study;
- (21) Plan to change previously used skin care products during the study period;
- (22) Other conditions deemed unsuitable for inclusion by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
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
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 1:1 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 (duration:Use 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).
Read the 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:
- Reduction of facial or periocular wrinkles based on Fitzpatrick score (12 weeks);
- 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.
- Conditions
- Skin Wrinkles
- Being tested
- Home radiofrequency skin treatment instrument, Ultrasonic coupler for medical purposes
- Keywords
- Rf beauty device for home use, Treatment of facial or periorbital wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home radiofrequency skin treatment instrumentDevice
Subjects in the experimental group were treated with the test instrument combined with medical ultrasonic coupler for 5 days a week according to the prescribed use method (duration of use: 10 minutes for the whole face, continuous use twice a day, a total of 20 minutes) for 12 weeks. To evaluate the reduction of wrinkles before and after treatment and the changes of laboratory instruments.
Ultrasonic coupler for medical purposesOther
In control group, medical ultrasonic coupler was evenly applied on face and orbit for 5 days a week (duration: 20 minutes) for 12 consecutive days Week. To evaluate the reduction of wrinkles and the change of laboratory instruments before and after use.
| Study group | Role | What they receive |
|---|---|---|
| Home radiofrequency skin treatment instrument | Experimental | Radiofrequency skin therapy instrument with medical ultrasound coupler is used for 20 minutes a day, 5 days a week Receives: Device: Home radiofrequency skin treatment instrument |
| Medical ultrasound coupler | Placebo comparator | Medical ultrasound coupler is applied to the face for 20 minutes a day, 5 days a week Receives: Other: Ultrasonic coupler for medical purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle reduction efficiency based on Fitzpatrick score
After 12 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline.
Measured: 12th week
Secondary outcomes (9)
Wrinkle reduction efficiency based on Fitzpatrick score
After 6 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline.
Measured: 6th week
R2 values measured by the Cutometer dual MPA580
The R2 values of the two groups were compared after 6 weeks /12 weeks after using the RF instrument.
Measured: 6th week\12th week
F4 values measured by the Cutometer dual MPA580
The F4 values of the two groups were compared after 6 weeks /12 weeks after using the RF instrument.
Measured: 6th week\12th week
PRIMOS-CR measures the length of crow's feet wrinkles
PRIMOS-CR measured crow's feet and compared the length of wrinkles between the two groups Quantity
Measured: 6th week\12th week
PRIMOS-CR measures the length of under-eye lines wrinkles
PRIMOS-CR measured under-eye lines and compared the length of wrinkles between the two groups Quantity
Measured: 6th week\12th week
PRIMOS-CR measures the number of crow's feet wrinkles
PRIMOS-CR measured crow's feet and compared the number of wrinkles between the two groups length
Measured: 6th week\12th week
PRIMOS-CR measures the number of under-eye lines wrinkles
PRIMOS-CR measured under-eye lines and compared the number of wrinkles between the two groups length
Measured: 6th week\12th week
Lower face sag evaluation
According to the researchers' Skin Aging Atlas, skin aging Type 2 Asian Edition , to assess the severity of the subject's lower bilateral sagging.
Measured: 6th week\12th week
Subject satisfaction evaluation
The participants received a questionnaire at the last visit, which mainly included the skin improvement effect of the product And the satisfaction degree of ease of operation
Measured: 6th week\12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start17 Apr 2023
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The method of randomized control and evaluator blindness is suitable for screening A total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glomed(HN)Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Lai, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441799
- Sponsor's protocol ID
- YM-1
- Acronym
- YM-1
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06441799
- Acronym / sponsor ID
- YM-1 / YM-1
- Conditions
- Skin Wrinkles
- Keywords
- Rf beauty device for home use, Treatment of facial or periorbital wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Glomed(HN)Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1:1 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 (duration:Use 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).
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:
- Reduction of facial or periocular wrinkles based on Fitzpatrick score (12 weeks);
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The method of randomized control and evaluator blindness is suitable for screening A total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group)
| Arm | Type | Receives |
|---|---|---|
| Home radiofrequency skin treatment instrument | Experimental | Device: Home radiofrequency skin treatment instrumentRadiofrequency skin therapy instrument with medical ultrasound coupler is used for 20 minutes a day, 5 days a week |
| Medical ultrasound coupler | Placebo comparator | Other: Ultrasonic coupler for medical purposesMedical ultrasound coupler is applied to the face for 20 minutes a day, 5 days a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1) Adults aged 18 and above, male or female;
- (2) Fitzpatrick's wrinkles and elasticity scores around the face and eyes were 2-7 points (on-site assessment);
- (3) To avoid sun exposure during the test;
- (4) Be able to read Chinese and accurately understand, and sign the informed consent of the test;
- (5) can cooperate with and participate in the test return visit time, and timely reflect their own health status or any changes in drugs, adverse reaction symptoms;
Key exclusion criteria (22 listed)
- (1) Abnormal vital signs (blood pressure, pulse, body temperature), except for minor abnormalities that are not clinically significant as determined by the doctor;
- (2) There is a pacemaker or internal defibrillator in the body, or any other active electrical implant anywhere in the body;
- (3) The treatment area has permanent implants, such as metal plates and screws (e.g. dentures, metal teeth), silicone implants or injected chemicals;
- (4) There is or has been a history of skin cancer, or any other type of cancer, or malignant pre-nevus;
- (5) serious comorbidities, such as heart disease, epilepsy, high blood pressure and liver or kidney disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home radiofrequency skin treatment instrumentSubjects in the experimental group were treated with the test instrument combined with medical ultrasonic coupler for 5 days a week according to the prescribed use method (duration of use: 10 minutes for the whole face, continuous use twice a day, a total of 20 minutes) for 12 weeks. To evaluate the reduction of wrinkles before and after treatment and the changes of laboratory instruments. | Device | Home radiofrequency skin treatment instrument |
| Ultrasonic coupler for medical purposesIn control group, medical ultrasonic coupler was evenly applied on face and orbit for 5 days a week (duration: 20 minutes) for 12 consecutive days Week. To evaluate the reduction of wrinkles and the change of laboratory instruments before and after use. | Other | Medical ultrasound coupler |
Primary outcome
Wrinkle reduction efficiency based on Fitzpatrick score
Time frame: 12th week
After 12 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline.
9 secondary outcomes
Wrinkle reduction efficiency based on Fitzpatrick score
Time frame: 6th week
R2 values measured by the Cutometer dual MPA580
Time frame: 6th week\12th week
F4 values measured by the Cutometer dual MPA580
Time frame: 6th week\12th week
PRIMOS-CR measures the length of crow's feet wrinkles
Time frame: 6th week\12th week
PRIMOS-CR measures the length of under-eye lines wrinkles
Time frame: 6th week\12th week
PRIMOS-CR measures the number of crow's feet wrinkles
Time frame: 6th week\12th week
PRIMOS-CR measures the number of under-eye lines wrinkles
Time frame: 6th week\12th week
Lower face sag evaluation
Time frame: 6th week\12th week
Subject satisfaction evaluation
Time frame: 6th week\12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Skin Wrinkles
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Lai, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home radiofrequency skin treatment instrument and Ultrasonic coupler for medical purposes in people with Skin Wrinkles, run by Glomed(HN)Co.Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkle reduction efficiency based on Fitzpatrick score (time frame: 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.