Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.
NCT ID: NCT06111482
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-09-28
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IPL only
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.
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.
RF Microneedling Only
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.
Radiofrequency microneedling device
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.
RF Only
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.
Radiofrequency device
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.
Combination
Group D will receive combination treatments and will be treated with 2 or more of the study devices.
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.
Radiofrequency microneedling device
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 device
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 devices
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.
Interventions
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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.
Radiofrequency microneedling device
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 device
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 devices
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
22 Years
ALL
No
Sponsors
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Cynosure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sean Doherty
Role: PRINCIPAL_INVESTIGATOR
Cynosure, LLC
Locations
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Cynosure
Westford, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Sean Doherty
Role: primary
Other Identifiers
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EUN-PL01-2023
Identifier Type: -
Identifier Source: org_study_id
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