Improve Facial WrinklesNCT07894120
Clinical Trial Protocol for the Effectiveness and Safety of Radiofrequency Skin Therapy Equipment in Improving Facial Skin Wrinkles
A study testing Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles in people with Improve Facial Wrinkles, run by Peking University Third Hospital at 1 site in China.
Trial summary
Evaluate the clinical efficacy and safety of the radiofrequency skin therapy device (model specification: RFM-01) produced by ReFumei (Hunan) Technology Co., Ltd. for improving facial skin wrinkles Read more about this study
- Who is it for?
- Ages 23 to 60 years
- Conditions the study is for
- Improve Facial Wrinkles
- What is being tested?
- Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2023to 2 Apr 2024
- 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 23 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ① Healthy adults aged 20 to 60, regardless of gender;
- Fitzpatrick skin classification II-IV (see Appendix 1 for details); ③ Facial Fitzpatrick wrinkles and elasticity score>3 points (see Attachment 2 for details); ④ Agree not to take any measures that affect the facial skin condition during the trial period, such as microcrystalline skin rejuvenation, peeling, acne treatment, filler implantation, lifting thread, botulinum toxin treatment, or laser treatment, etc; ⑤ Agree to take and collect facial photos for research purposes and publish them for use in publications; Understand the purpose of this experiment and voluntarily participate in it, sign the informed consent form.
Who cannot join
- ① Merge severe cardiovascular and cerebrovascular diseases or other systemic diseases.
- Combined with systemic diseases or local skin diseases that may affect wound healing, such as diabetes with poor blood sugar control, immune system diseases, scar constitution, local skin inflammation, skin cancer, etc.
- The treatment area combines the following situations:
- 1) Suffering from any skin disease (such as acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, herpes zoster, infection or scarring, etc.); 2) Suffering from active skin inflammation; 3) Abnormal skin sensation; 4) The presence of metal stents or other metal implants; 5) Significant muscle atrophy/excessive weakness; 6) Having perforations or tattoos.
- Within the past 30 days, have received any form of facial skin grinding, chemical peeling, laser freckle removal, or IPL treatment.
- Within the past 90 days, the treatment area has received autologous fat grafting, fractional laser, fillers, botulinum toxin therapy, liposuction, or other types of radiofrequency therapy.
Show all 14Show fewer
- Within the past 6 months, have received traction therapy;
- There is a history of medication or concomitant medication during the study period, including:
- 1) Take nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, etc. within 10 days before treatment or within 3 days after treatment; 2) Take acetaminophen within 24 hours before treatment; 3) Antiplatelet therapy should be administered within 72 hours prior to treatment; 4) Perform anticoagulant therapy within 2 weeks before or during treatment; 5) Local steroid therapy within 4 weeks prior to treatment and during the study period, or systemic corticosteroid therapy within 6 months prior to treatment; 6) Administer immunosuppressive drugs within 6 months prior to treatment and during the study period.
- ⑧ History of allergies to the required materials and ingredients during the treatment process.
- ⑨ Individuals who are currently participating or have participated in clinical trials of other medical devices or drugs within the past 90 days.
- ⑩ Pregnant women, lactating women, or those with fertility plans during the trial period.
- ⑪ Those with severe mental illness who cannot cooperate.
- ⑫ The researchers believe that participants are not suitable for this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
Medical Science Research Ethics Committee of Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Evaluate the clinical efficacy and safety of the radiofrequency skin therapy device (model specification: RFM-01) produced by ReFumei (Hunan) Technology Co., Ltd. for improving facial skin wrinkles
- Conditions
- Improve Facial Wrinkles
- Being tested
- Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles, The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinklesDevice
The instrument used is a similar product that has already been launched on the market
The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinklesDevice
The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. | Experimental | Not described Receives: Device: Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles |
| The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co | Other | Not described Receives: Device: The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main effectiveness indicators
Overall clinical efficacy rate，Using the Fitzpatrick Skin Wrinkle and Elasticity Rating Scale, a four level evaluation was conducted on the improvement rate of wrinkles before and after treatment, based on the pre-treatment baseline: significant improvement, moderate improvement, mild improvement, and no improvement. ① Significant improvement: Wrinkle improvement rate>75%; ② Moderate improvement: The wrinkle improvement rate is between 51% and 75%; ③ Mild improvement: The wrinkle improvement rate is between 25% and 50%; ④ No improvement: Wrinkle improvement rate<25%. Overall clinical efficacy rate=(number of significantly improved cases+number of moderately improved cases+number of mildly improved cases)/total cases.
Measured: 90 days after treatment
Main safety indicators
Measure the respiratory frequency of the subject using a pulmonary function meter，in beats per minute
Measured: Before and immediately after treatment
Main safety indicators
Adverse event incidence rate
Measured: Before intervention, during treatment, and 90 days after treatment
Secondary effectiveness indicators
VISIA Facial Rating
Measured: On the 7th, 30th, and 90th day after treatment
Secondary effectiveness indicators
Visual Analogue Scale
Measured: Immediately after treatment
Secondary effectiveness indicators
Skin reaction score
Measured: Immediately after treatment, 7 days after treatment
Secondary effectiveness indicators
Using a satisfaction rating scale，Calculate the proportion of satisfied patients
Measured: 90 days after treatment
Main safety indicators
Using a thermometer to measure the patient's body temperature，Body temperature unit Celsius
Measured: Before and immediately after treatment
Main safety indicators
Measure the subject's pulse using a pulse oximeter, in beats per minute
Measured: Before and immediately after treatment
Main safety indicators
Measure the subject's blood pressure using a sphygmomanometer, in mmHg
Measured: Before and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start12 Jun 2023
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Improve Facial WrinklesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894120
- Sponsor's protocol ID
- D2023076
- Status last verified
- Jun 2023
- First submitted
- 8 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaffary F, Nilforoushzadeh MA, Zarkoob H. Patient satisfaction and efficacy of accent radiofrequency for facial skin wrinkle reduction. J Res Med Sci. 2013 Nov;18(11):970-5.
PubMed 24523783Paasch U, Bodendorf MO, Grunewald S, Simon JC. Skin rejuvenation by radiofrequency therapy: methods, effects and risks. J Dtsch Dermatol Ges. 2009 Mar;7(3):196-203. doi: 10.1111/j.1610-0387.2008.06780.x. Epub 2008 Jun 17. English, German.
PubMed 18564210Ekelem C, Thomas L, Van Hal M, Valdebran M, Lotfizadeh A, Mlynek K, Mesinkovska NA. Radiofrequency Therapy and Noncosmetic Cutaneous Conditions. Dermatol Surg. 2019 Jul;45(7):908-930. doi: 10.1097/DSS.0000000000001925.
PubMed 30893163Fisher GH, Jacobson LG, Bernstein LJ, Kim KH, Geronemus RG. Nonablative radiofrequency treatment of facial laxity. Dermatol Surg. 2005 Sep;31(9 Pt 2):1237-41; discussion 1241. doi: 10.1111/j.1524-4725.2005.31932.
PubMed 16176777Edwards AF, Massaki AB, Fabi S, Goldman M. Clinical efficacy and safety evaluation of a monopolar radiofrequency device with a new vibration handpiece for the treatment of facial skin laxity: a 10-month experience with 64 patients. Dermatol Surg. 2013 Jan;39(1 Pt 1):104-10. doi: 10.1111/dsu.12010. Epub 2012 Nov 15.
PubMed 23153312Abraham MT, Mashkevich G. Monopolar radiofrequency skin tightening. Facial Plast Surg Clin North Am. 2007 May;15(2):169-77, v. doi: 10.1016/j.fsc.2007.01.005.
PubMed 17544932
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol for the Effectiveness and Safety of Radiofrequency Skin Therapy Equipment in Improving Facial Skin Wrinkles
- ClinicalTrials.gov ID
- NCT07894120
- Acronym / sponsor ID
- D2023076
- Conditions
- Improve Facial Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 26 Oct 2026 (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.
Evaluate the clinical efficacy and safety of the radiofrequency skin therapy device (model specification: RFM-01) produced by ReFumei (Hunan) Technology Co., Ltd. for improving facial skin wrinkles
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. | Experimental | Device: Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles |
| The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co | Other | Device: The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles |
Who may qualify
- Ages
- 23 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ① Healthy adults aged 20 to 60, regardless of gender;
Key exclusion criteria (14 listed)
- ① Merge severe cardiovascular and cerebrovascular diseases or other systemic diseases.
- 1) Suffering from any skin disease (such as acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, herpes zoster, infection or scarring, etc.); 2) Suffering from active skin inflammation; 3) Abnormal skin sensation; 4) The presence of metal stents or other metal implants; 5) Significant muscle atrophy/excessive weakness; 6) Having perforations or tattoos.
- 1) Take nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, etc. within 10 days before treatment or within 3 days after treatment; 2) Take acetaminophen within 24 hours before treatment; 3) Antiplatelet therapy should be administered within 72 hours prior to treatment; 4) Perform anticoagulant therapy within 2 weeks before or during treatment; 5) Local steroid therapy within 4 weeks prior to treatment and during the study period, or systemic corticosteroid therapy within 6 months prior to treatment; 6) Administer immunosuppressive drugs within 6 months prior to treatment and during the study period.
- ⑧ History of allergies to the required materials and ingredients during the treatment process.
- ⑨ Individuals who are currently participating or have participated in clinical trials of other medical devices or drugs within the past 90 days.
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 |
|---|---|---|
| Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinklesThe instrument used is a similar product that has already been launched on the market | Device | Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. |
| The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinklesThe control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co., Ltd. to improve facial wrinkles | Device | The control group subjects used the radiofrequency therapy device produced by Israel Flyton Laser Co |
Primary outcome
Main effectiveness indicators
Time frame: 90 days after treatment
Overall clinical efficacy rate，Using the Fitzpatrick Skin Wrinkle and Elasticity Rating Scale, a four level evaluation was conducted on the improvement rate of wrinkles before and after treatment, based on the pre-treatment baseline: significant improvement, moderate improvement, mild improvement, and no improvement. ① Significant improvement: Wrinkle improvement rate>75%; ② Moderate improvement: The wrinkle improvement rate is between 51% and 75%; ③ Mild improvement: The wrinkle improvement rate is between 25% and 50%; ④ No improvement: Wrinkle improvement rate<25%. Overall clinical efficacy rate=(number of significantly improved cases+number of moderately improved cases+number of mildly improved cases)/total cases.
Main safety indicators
Time frame: Before and immediately after treatment
Measure the respiratory frequency of the subject using a pulmonary function meter，in beats per minute
Main safety indicators
Time frame: Before intervention, during treatment, and 90 days after treatment
Adverse event incidence rate
Secondary effectiveness indicators
Time frame: On the 7th, 30th, and 90th day after treatment
VISIA Facial Rating
Secondary effectiveness indicators
Time frame: Immediately after treatment
Visual Analogue Scale
Secondary effectiveness indicators
Time frame: Immediately after treatment, 7 days after treatment
Skin reaction score
Secondary effectiveness indicators
Time frame: 90 days after treatment
Using a satisfaction rating scale，Calculate the proportion of satisfied patients
Main safety indicators
Time frame: Before and immediately after treatment
Using a thermometer to measure the patient's body temperature，Body temperature unit Celsius
Main safety indicators
Time frame: Before and immediately after treatment
Measure the subject's pulse using a pulse oximeter, in beats per minute
Main safety indicators
Time frame: Before and immediately after treatment
Measure the subject's blood pressure using a sphygmomanometer, in mmHg
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 26 Oct 2026.
- Results publication: PubMed 24523783Jaffary F, Nilforoushzadeh MA, Zarkoob H. Patient satisfaction and efficacy of accent radiofrequency for facial skin wrinkle reduction. J Res Med Sci. 2013 Nov;18(11):970-5.
- Results publication: PubMed 18564210Paasch U, Bodendorf MO, Grunewald S, Simon JC. Skin rejuvenation by radiofrequency therapy: methods, effects and risks. J Dtsch Dermatol Ges. 2009 Mar;7(3):196-203. doi: 10.1111/j.1610-0387.2008.06780.x. Epub 2008 Jun 17. English, German.
- Results publication: PubMed 30893163Ekelem C, Thomas L, Van Hal M, Valdebran M, Lotfizadeh A, Mlynek K, Mesinkovska NA. Radiofrequency Therapy and Noncosmetic Cutaneous Conditions. Dermatol Surg. 2019 Jul;45(7):908-930. doi: 10.1097/DSS.0000000000001925.
- Results publication: PubMed 16176777Fisher GH, Jacobson LG, Bernstein LJ, Kim KH, Geronemus RG. Nonablative radiofrequency treatment of facial laxity. Dermatol Surg. 2005 Sep;31(9 Pt 2):1237-41; discussion 1241. doi: 10.1111/j.1524-4725.2005.31932.
- Results publication: PubMed 23153312Edwards AF, Massaki AB, Fabi S, Goldman M. Clinical efficacy and safety evaluation of a monopolar radiofrequency device with a new vibration handpiece for the treatment of facial skin laxity: a 10-month experience with 64 patients. Dermatol Surg. 2013 Jan;39(1 Pt 1):104-10. doi: 10.1111/dsu.12010. Epub 2012 Nov 15.
- Results publication: PubMed 17544932Abraham MT, Mashkevich G. Monopolar radiofrequency skin tightening. Facial Plast Surg Clin North Am. 2007 May;15(2):169-77, v. doi: 10.1016/j.fsc.2007.01.005.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency skin therapy equipment developed and produced by ReFumei (Hunan) Technology Co., Ltd. improves facial wrinkles in people with Improve Facial Wrinkles, run by Peking University Third Hospital 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 2 inclusion and 14 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 26 Oct 2026. 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. 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?
Main effectiveness indicators (time frame: 90 days after treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07894120, which also lists 6 linked publications.
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 26 Oct 2026.