Feasibility Study for Radiofrequency Microneedling Device for Skin Conditions
This study is looking at a RadioFrequency Microneedling Device to treat skin conditions like wrinkles, fine lines, crepey skin, acne scars, and active acne. The device works by using electrocoagulation and hemostasis (stopping bleeding) in soft tissues. We want to see how satisfied people are with the treatments. You might be able to join if you are a healthy non-smoker between 22 and 65 years old with certain skin types (Fitzpatrick skin type I to VI). The study is currently recruiting participants.
- Study design
- This is an interventional study planning to enroll up to 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would attend a screening visit and may receive up to 5 treatments. You must be able to attend all visits and not have other procedures on the treated area during the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your satisfaction with the treatments will be measured 30 days after your last treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05987319
Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions
UNKNOWN
NAAges 22–65InterventionalTreatmentCynosure, Inc.
~20 participants
Updated 2024-05-07 on ClinicalTrials.gov
What's tested:RadioFrequency Microneedling Device
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
% of subjects satisfied with treatments.
Measured over 30 days post last treatment
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
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.
What this trial measures
- % of subjects satisfied with treatments.30 days post last treatment
% of subjects satisfied with the treatment will the reported at the 30 days follow up.