Dermatologic ConditionsNCT06023303
Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin
A study testing Potenza and Morpheus in people with Dermatologic Conditions, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) 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 18 to 65 years
- Conditions the study is for
- Dermatologic Conditions
- What is being tested?
- Potenza and Morpheus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 10 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A healthy male or female between the age of 18-65 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 received fillers or neurotoxin injections within the past 3 months.
- 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).
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- 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 keloid formation propensity.
- Subjects with electronic implants such as cardiac defibrillator. It may interfere with the operation of electronic implants or damage the implants, causing risks.
- The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confuse study results or may interfere significantly with the subject's participation
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) 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 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2 groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).
- Conditions
- Dermatologic Conditions
- Being tested
- Potenza, Morpheus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PotenzaDevice
The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.
MorpheusDevice
The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Group A- Split face | Experimental | Group A will receive split face treatments with the Potenza and Morpheus. Randomization will not be used for enrolling subjects to a group but will be used for Group A to determine which side of the face will receive which device. Receives: Device: Potenza; Device: Morpheus |
| Group B- none split face | Experimental | Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Receives: Device: Potenza; Device: Morpheus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain reported during treatment.
The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain).
Measured: procedure (during device treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start21 Jun 2023
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic ConditionsStudies 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
- Subjects will be treated with the Potenza device on one side of the face and will receive treatment with Morpheus device on the other side of the face.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Doherty, Principal investigator, Cynosure, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023303
- Sponsor's protocol ID
- 7043-PM01-2023
- Status last verified
- Jan 2024
- First submitted
- 15 Aug 2023
- Last updated
- 9 Jan 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin
- ClinicalTrials.gov ID
- NCT06023303
- Acronym / sponsor ID
- 7043-PM01-2023
- Conditions
- Dermatologic Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 5 Sep 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 Radiofrequency microneedling devices (Potenza and Morpheus) 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 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2 groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be treated with the Potenza device on one side of the face and will receive treatment with Morpheus device on the other side of the face.
| Arm | Type | Receives |
|---|---|---|
| Group A- Split face | Experimental | Device: Potenza, Device: MorpheusGroup A will receive split face treatments with the Potenza and Morpheus. Randomization will not be used for enrolling subjects to a group but will be used for Group A to determine which side of the face will receive which device. |
| Group B- none split face | Experimental | Device: Potenza, Device: MorpheusGroup B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A healthy male or female between the age of 18-65 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 (21 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 received fillers or neurotoxin injections within the past 3 months.
- The subject has a Pacemaker.
- The subject had previous use of gold thread skin rejuvenation.
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 |
|---|---|---|
| PotenzaThe Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth. | Device | Group A- Split face, Group B- none split face |
| MorpheusThe Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth. | Device | Group A- Split face, Group B- none split face |
Primary outcome
Maximum pain reported during treatment.
Time frame: procedure (during device treatment)
The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain).
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 9 Jan 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.
Sean Doherty principal investigator
Cynosure, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potenza and Morpheus in people with Dermatologic Conditions, 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 21 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 9 Jan 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?
Maximum pain reported during treatment. (time frame: procedure (during device 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 9 Jan 2024.