Dermatologic ConditionsNCT06111482
Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.
A study testing Intense pulsed light., Radiofrequency microneedling device and Radiofrequency device in people with Dermatologic Conditions, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dermatologic Conditions
- What is being tested?
- Intense pulsed light., Radiofrequency microneedling device and Radiofrequency device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A healthy male or female 22 years of age or older.
- Willing to undergo at least 1 treatment with the study device(s).
- Understands and accepts obligation not to receive any other procedures in 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 female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
- Is using systemic steroids (e.g., prednisone, dexamethasone) prior to or during the course of treatment.
- Is receiving or has received gold therapy.
- Is taking medications that alter the wound-healing response or has a history of healing problems.
- Has an active localized or systemic infection, or an open wound in area being treated.
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- Has a significant systemic illness, such as lupus, or an illness localized in area being treated.
- Has a seizure disorders triggered by light.
- Has a history of skin photosensitivity disorders.
- Has a history of hypertrophic scars or keloid formation.
- Has a history of radiation therapy in area to be treated.
- Received fillers or neurotoxin injections in the treatment area within the past 2 weeks.
- Has had a chemical or mechanical epilation within the last six weeks.
- Currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months to entering this study.
- 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.
- Radiofrequency Device Only:
- Has a Pacemaker
- Has any embedded electronic devices that give or receive a signal.
- Has electronic implants, such as 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.
- 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.
- Has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
- Is allergic to topical anesthetic
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cynosure
Westford, Massachusetts, 01886
Sean Doherty
About this study
The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.
Read the detailed description
Up to 50 subjects will be enrolled at 1 study center. Subjects will be enrolled into 4 groups: Group A, Group B, Group C, or Group D. Subjects may enroll in more than one group, however the last treatment in the previous group would be at least 30 days before the subject is enroll in the next group if treatment area is the same.
- Conditions
- Dermatologic Conditions
- Being tested
- Intense pulsed light., Radiofrequency microneedling device, Radiofrequency device, Combined energy devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense pulsed light.Device
The intense pulsed light (IPL) will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
Radiofrequency microneedling deviceDevice
The microneedling device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
Radiofrequency deviceDevice
The radio frequency device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
Combined energy devicesDevice
The combined energy devices will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.
| Study group | Role | What they receive |
|---|---|---|
| IPL only | Experimental | Group A will be treated with an intense pulsed light (IPL) device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar IPL device that is cleared for use by the FDA. Receives: Device: Intense pulsed light. |
| RF Microneedling Only | Experimental | Group B will be treated with a radiofrequency (RF) microneedling device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF microneedling device that is cleared for use by the FDA. Receives: Device: Radiofrequency microneedling device |
| RF Only | Experimental | Group C will be treated with an RF device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF device that is cleared for use by the FDA. Receives: Device: Radiofrequency device |
| Combination | Experimental | Group D will receive combination treatments and will be treated with 2 or more of the study devices. Receives: Device: Intense pulsed light.; Device: Radiofrequency microneedling device; Device: Radiofrequency device; Device: Combined energy devices |
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). This pain is recorded during when the patient is actively treated (when the patient comes in and receives a treatment from the device).
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 posted1 Nov 2023
- Study start28 Sep 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be treated with an intended pulsed light device. Subjects may also receive split treatments where one side of the face and/or body will be treated with the study device, and the contralateral side will be treated with a similar IPL device or a similar microneedling device. Randomization will not be used as the group the subject will be assigned to will be determined based on dermatologic condition the subject presents with and this will be determined by the Investigator.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- NCT06111482
- Sponsor's protocol ID
- EUN-PL01-2023
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.
- ClinicalTrials.gov ID
- NCT06111482
- Acronym / sponsor ID
- EUN-PL01-2023
- Conditions
- Dermatologic Conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 1 Nov 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 energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.
Detailed description
Up to 50 subjects will be enrolled at 1 study center. Subjects will be enrolled into 4 groups: Group A, Group B, Group C, or Group D. Subjects may enroll in more than one group, however the last treatment in the previous group would be at least 30 days before the subject is enroll in the next group if treatment area is the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be treated with an intended pulsed light device. Subjects may also receive split treatments where one side of the face and/or body will be treated with the study device, and the contralateral side will be treated with a similar IPL device or a similar microneedling device. Randomization will not be used as the group the subject will be assigned to will be determined based on dermatologic condition the subject presents with and this will be determined by the Investigator.
| Arm | Type | Receives |
|---|---|---|
| IPL only | Experimental | Device: Intense pulsed light.Group A will be treated with an intense pulsed light (IPL) device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar IPL device that is cleared for use by the FDA. |
| RF Microneedling Only | Experimental | Device: Radiofrequency microneedling deviceGroup B will be treated with a radiofrequency (RF) microneedling device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF microneedling device that is cleared for use by the FDA. |
| RF Only | Experimental | Device: Radiofrequency deviceGroup C will be treated with an RF device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF device that is cleared for use by the FDA. |
| Combination | Experimental | Device: Intense pulsed light., Device: Radiofrequency microneedling device, Device: Radiofrequency device, Device: Combined energy devicesGroup D will receive combination treatments and will be treated with 2 or more of the study devices. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A healthy male or female 22 years of age or older.
- Willing to undergo at least 1 treatment with the study device(s).
- Understands and accepts obligation not to receive any other procedures in 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 (22 listed)
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
- Is using systemic steroids (e.g., prednisone, dexamethasone) prior to or during the course of treatment.
- Is receiving or has received gold therapy.
- Is taking medications that alter the wound-healing response or has a history of healing problems.
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 |
|---|---|---|
| Intense pulsed light.The intense pulsed light (IPL) will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. | Device | Combination, IPL only |
| Radiofrequency microneedling deviceThe microneedling device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. | Device | Combination, RF Microneedling Only |
| Radiofrequency deviceThe radio frequency device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. | Device | Combination, RF Only |
| Combined energy devicesThe combined energy devices will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands. | Device | Combination |
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). This pain is recorded during when the patient is actively treated (when the patient comes in and receives a treatment from the device).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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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 Intense pulsed light., Radiofrequency microneedling device and Radiofrequency device 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 22 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 1 Nov 2023. 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?
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 1 Nov 2023.