WrinkleNCT05987319
Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions
A study testing RadioFrequency Microneedling Device in people with Wrinkle and Fine Lines, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Wrinkle, Fine Lines, Crepey Skin
- What is being tested?
- RadioFrequency Microneedling Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A healthy, non-smoking male or female between the age of 22-65 years old.
- Fitzpatrick skin type I to VI.
- Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- Understands and accepts the obligation and is logistically able to be present for all visits.
- Is willing to comply with all requirements of the study and sign the informed consent document.
Who cannot join
- Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 1 month prior to entering this study.
- The subject has a pacemaker.
- The subject had previous use of gold thread skin rejuvenation.
- The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated).
- The subject has a metal implant that interferes with the transmission of energy to the electrical field.
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- The subject has any embedded electronic devices that give or receive a signal.
- The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant.
- The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area.
- The subject is allergic to gold.
- The subject has an unrealistic expectation of the results: this is not plastic surgery, and all subjects should be fully informed of the treatment's expected results.
- The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
- The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated: this treatment will be ineffective.
- The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
- The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti- inflammatories or anticoagulants.
- The subject has a history of bleeding coagulopathies.
- The subject is allergic to topical anesthetic.
- The subject has any of the following conditions:
- Diabetes
- Epilepsy
- Autoimmune disease
- Herpes simplex
- HIV
- Hypertension
- Dermatitis
- The subject has keloid formation propensity.
- Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
- The subject has any condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound study results or may interfere.
- significantly with the subject's participation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cynosure, Inc.
Westford, Massachusetts, 01886
Sean Doherty
Sean Doherty
About this study
Official title: Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions.
The goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
Read the detailed description
Up to 12 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups. Group A will receive treatments on the face, neck, and/or body. Group B will receive split-face treatments where each side of the face may be treated with different tips. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments.
- Conditions
- Wrinkle, Fine Lines, Crepey Skin, Acne Scars, Active Acne, Enlarged Pores
- Being tested
- RadioFrequency Microneedling Device
- Medical subject headings
- Striae Distensae, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadioFrequency Microneedling DeviceDevice
RadioFrequency device will be used for the treatment of dermatologic conditions.
| Study group | Role | What they receive |
|---|---|---|
| General Treatment | Experimental | Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins. Receives: Device: RadioFrequency Microneedling Device |
| Split-face treatment | Experimental | Subjects will receive split-face treatments where each side of the face may be treated with different tips. Receives: Device: RadioFrequency Microneedling Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of subjects satisfied with treatments.
% of subjects satisfied with the treatment will the reported at the 30 days follow up.
Measured: 30 days post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start24 Jul 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987319
- Sponsor's protocol ID
- CYN20-RF-MN-02
- Status last verified
- May 2024
- First submitted
- 3 Aug 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions.
- ClinicalTrials.gov ID
- NCT05987319
- Acronym / sponsor ID
- CYN20-RF-MN-02
- Conditions
- Wrinkle, Fine Lines, Crepey Skin, Acne Scars, Active Acne, Enlarged Pores
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 14 Aug 2023 (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 goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
Detailed description
Up to 12 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups. Group A will receive treatments on the face, neck, and/or body. Group B will receive split-face treatments where each side of the face may be treated with different tips. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Treatment | Experimental | Device: RadioFrequency Microneedling DeviceSubjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins. |
| Split-face treatment | Experimental | Device: RadioFrequency Microneedling DeviceSubjects will receive split-face treatments where each side of the face may be treated with different tips. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A healthy, non-smoking male or female between the age of 22-65 years old.
- Fitzpatrick skin type I to VI.
- Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- Understands and accepts the obligation and is logistically able to be present for all visits.
- Is willing to comply with all requirements of the study and sign the informed consent document.
Key exclusion criteria (29 listed)
- Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 1 month prior to entering this study.
- The subject has a pacemaker.
- The subject had previous use of gold thread skin rejuvenation.
- The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated).
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 Microneedling DeviceRadioFrequency device will be used for the treatment of dermatologic conditions. | Device | General Treatment, Split-face treatment |
Primary outcome
% of subjects satisfied with treatments.
Time frame: 30 days post last treatment
% of subjects satisfied with the treatment will the reported at the 30 days follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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.
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 Microneedling Device in people with Wrinkle and Fine Lines, run by Cynosure, Inc. 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 5 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 7 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Trimper (9782564200, jamie.trimper@cynosure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of subjects satisfied with treatments. (time frame: 30 days post last treatment). 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 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.