Wrinkle ReductionASEMRSTDNCT06623214
Assessment of the Safety and Effectiveness of a Micro-RF Skin Treatment Device (nebulyft）
A study testing nebulyft in people with Wrinkle Reduction, run by Hangzhou Rebecca Medical Science and Technology Ltd. at 1 site in United States.
Trial summary
The objective of the study is to evaluate the safety, efficacy and usage compliance of the home-use device nebulyft for self-treatment of wrinkles appearance. The participants do treatment 5 time /week and last 4 weeks. Each treatment takes 16min to complete. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Wrinkle Reduction
- What is being tested?
- nebulyft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 13 Aug 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects received oral and electronic consent in accordance with local laws and regulations. Informed consent explains the nature and purpose of the study and the potential risks involved in the study, and emphasizes the voluntary nature of the test, and the subjects can exit the study at any time for any reason. All subjects can ask questions about the research and give sufficient time before signing. All informed consent must be signed before the start of the study.
- Adult subjects aged 25-65.
- The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, including the permission to use photography.
- The subjects should be willing to comply with the study procedure and schedule, including the follow-up visits, and will refrain from using any other or similar treatment technologies (i.e., Laser, RF, IR) for the facial condition.
- The subjects will carry on with their usual diet and exercise and will not have a significant weight change during the study.
- The subjects are able to read the User Manual in English.
- The subjects should have II-IV Fitzpatrick wrinkle skin type.
- The subjects should have visible facial wrinkles.
Who cannot join
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles per investigator\'s discretion.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases per investigator\'s discretion.
- Pregnancy or nursing, as well as 3-6 months post-childbirth.
- History of bleeding coagulopathies, or prolonged use of anticoagulants (daily aspirin dosing of 81 mg is acceptable).
Show all 15Show fewer
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medication per investigator\'s discretion.
- Subjects with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
- Poorly controlled endocrine disorders, such as diabetes or thyroid abnormality per investigator\'s discretion.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash per investigator\'s discretion.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin per investigator\'s discretion.
- Any surgery in treatment area within 3 months prior to treatment or before complete healing.
- Injected fillers in the treatment area in the last 6 months and Botox in the treatment area in the last 3 month.
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- As per the practitioner\'s discretion, refrain from treating any condition that might make it unsafe for the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
DSC Laser Skin Care Center
San Gabriel, California, 91776
About this study
Official title: Assessment of the Safety and Effectiveness of a Micro Radiofrequency Skin Treatment Device (nebulyft)
The objective of the study is to evaluate the safety, efficacy and usage compliance of the home-use device nebulyft for self-treatment of wrinkles appearance. The participants do treatment 5 time /week and last 4 weeks. Each treatment takes 16min to complete. Photographs will be taken before treatment and 1 month after the completion of treatment to compare the wrinkle scale.
Read the detailed description
This is a single-arm prospective study aimed at evaluating the safety and efficacy of nebulyft device treatment of facial areas. Nebulyft device is a low-power, radio frequency device designed to reduce facial wrinkles. 42 subjects will be enrolled in a single clinical site.
The included subjects will use the device at specified areas, including the cheek (for nasolabial fold lines), and outer eye corners (for crow\'s feet lines). Each side of the nasolabial fold receives 4 minutes of treatment, and each outer eye corner receives 4 minutes of treatment too. The total time for each treatment is 16 minutes. The study consists of at least five wrinkle reduction treatments a week at home for four consecutive weeks. The first treatment session will be conducted under the supervision of the principal investigator (PI), and the remaining sessions will be conducted at home, with remote assistance from the PI when necessary.
A Self-selection and Labeling Comprehension study will be conducted that includes three main questions regarding the intended use of the device, treatment areas, and the possibility of using the device according to the contraindications.
A usability study will be conducted as part of the clinical study. The study was divided into several steps. The PI must observe the test subject to ensure compliance with all the procedures.
In the first visit, the independent treatment for wrinkle reduction was performed under the investigator's observation. Patients were asked to rate the pain level and note any problems/difficulties during the treatments.
The subjects perform treatment at home for 4 continuous weeks and return for photography at the end of the treatment. They will be asked to rate the pain level of the treatment during the visit.
The subjects take final photographs 4 weeks after finishing the treatment and rate the overall satisfaction of the treatment.
- Conditions
- Wrinkle Reduction
- Being tested
- nebulyft
- Keywords
- wrinkle reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulyftDevice
Micro Radiofrequency Skin Treatment Device(nebulyft)
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | receive treatment Receives: Device: nebulyft |
What is being measured
The primary outcome is the main question the study is designed to answer.
wrinkle improvement at least one score point of Fitzpatrick wrinkle scale
Three independent board-certified dermatologists assess patient photographs taken at baseline (before treatment initiation) and compare them to those captured one month after completing the home-based treatment using the Fitzpatrick wrinkle scale, which ranges from 1 (least wrinkles) to 9 (most wrinkles). A treatment is considered successful if at least two of the three evaluators observe reduction of at least one score-point in any of the treated areas; otherwise, it is deemed a failure.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
subjective wrinkle improvement in wrinkle appearance as measured by satisfactory questionnaires
Subjective wrinkle improvement is assessed based on participants responses to satisfaction questionnaires. There are four questions in total, each rated on a scale of 1 to 4, where 1 indicates very dissatisfied; and 4 indicates very satisfied. The scores from all four questions are summed up, and the total score is used to determine the participants\' overall satisfaction with the treatment results.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start7 Jun 2024
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkle ReductionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical design adopted the single-group target value method
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Rebecca Medical Science and Technology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Shum, MD, Principal investigator, DSC Laser & Skin Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623214
- Sponsor's protocol ID
- RBTBAP202404 V1.0
- Acronym
- ASEMRSTD
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: the data will be published on paper
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Effectiveness of a Micro Radiofrequency Skin Treatment Device (nebulyft)
- ClinicalTrials.gov ID
- NCT06623214
- Acronym / sponsor ID
- ASEMRSTD / RBTBAP202404 V1.0
- Conditions
- Wrinkle Reduction
- Keywords
- wrinkle reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hangzhou Rebecca Medical Science and Technology Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 2 Oct 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.
The objective of the study is to evaluate the safety, efficacy and usage compliance of the home-use device nebulyft for self-treatment of wrinkles appearance. The participants do treatment 5 time /week and last 4 weeks. Each treatment takes 16min to complete. Photographs will be taken before treatment and 1 month after the completion of treatment to compare the wrinkle scale.
Detailed description
This is a single-arm prospective study aimed at evaluating the safety and efficacy of nebulyft device treatment of facial areas. Nebulyft device is a low-power, radio frequency device designed to reduce facial wrinkles. 42 subjects will be enrolled in a single clinical site.
The included subjects will use the device at specified areas, including the cheek (for nasolabial fold lines), and outer eye corners (for crow\'s feet lines). Each side of the nasolabial fold receives 4 minutes of treatment, and each outer eye corner receives 4 minutes of treatment too. The total time for each treatment is 16 minutes. The study consists of at least five wrinkle reduction treatments a week at home for four consecutive weeks. The first treatment session will be conducted under the supervision of the principal investigator (PI), and the remaining sessions will be conducted at home, with remote assistance from the PI when necessary.
A Self-selection and Labeling Comprehension study will be conducted that includes three main questions regarding the intended use of the device, treatment areas, and the possibility of using the device according to the contraindications.
A usability study will be conducted as part of the clinical study. The study was divided into several steps. The PI must observe the test subject to ensure compliance with all the procedures.
In the first visit, the independent treatment for wrinkle reduction was performed under the investigator's observation. Patients were asked to rate the pain level and note any problems/difficulties during the treatments.
The subjects perform treatment at home for 4 continuous weeks and return for photography at the end of the treatment. They will be asked to rate the pain level of the treatment during the visit.
The subjects take final photographs 4 weeks after finishing the treatment and rate the overall satisfaction of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical design adopted the single-group target value method
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: nebulyftreceive treatment |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All subjects received oral and electronic consent in accordance with local laws and regulations. Informed consent explains the nature and purpose of the study and the potential risks involved in the study, and emphasizes the voluntary nature of the test, and the subjects can exit the study at any time for any reason. All subjects can ask questions about the research and give sufficient time before signing. All informed consent must be signed before the start of the study.
- Adult subjects aged 25-65.
- The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, including the permission to use photography.
- The subjects should be willing to comply with the study procedure and schedule, including the follow-up visits, and will refrain from using any other or similar treatment technologies (i.e., Laser, RF, IR) for the facial condition.
- The subjects will carry on with their usual diet and exercise and will not have a significant weight change during the study.
Key exclusion criteria (15 listed)
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles per investigator\'s discretion.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases per investigator\'s discretion.
- Pregnancy or nursing, as well as 3-6 months post-childbirth.
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 |
|---|---|---|
| nebulyftMicro Radiofrequency Skin Treatment Device(nebulyft) | Device | treatment |
Primary outcome
wrinkle improvement at least one score point of Fitzpatrick wrinkle scale
Time frame: From enrollment to the end of treatment at 8 weeks
Three independent board-certified dermatologists assess patient photographs taken at baseline (before treatment initiation) and compare them to those captured one month after completing the home-based treatment using the Fitzpatrick wrinkle scale, which ranges from 1 (least wrinkles) to 9 (most wrinkles). A treatment is considered successful if at least two of the three evaluators observe reduction of at least one score-point in any of the treated areas; otherwise, it is deemed a failure.
1 secondary outcome
subjective wrinkle improvement in wrinkle appearance as measured by satisfactory questionnaires
Time frame: From enrollment to the end of treatment at 8 weeks
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 3 Oct 2024.
- Individual participant dataSharing planned: Undecided. the data will be published on paper
Related trials for Wrinkle Reduction
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Recruiting
Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®.
Healthy Adult Females
Recruiting
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Photoaged Facial Skin, Photoaging
Active, not recruiting
A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area
Wrinkle Reduction
Active, not recruitingObservational study
Filler Post Market Survey (FIPS)
Wrinkle Reduction
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.
Tony Shum, MD principal investigator
DSC Laser & Skin Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nebulyft in people with Wrinkle Reduction, run by Hangzhou Rebecca Medical Science and Technology Ltd. at 1 site in United States.
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 8 inclusion and 15 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 3 Oct 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 United States. 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?
wrinkle improvement at least one score point of Fitzpatrick wrinkle scale (time frame: From enrollment to the end of treatment at 8 weeks). 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 3 Oct 2024.