Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.

Cynosure

Status: Enrolling

Conditions: Dermatologic Conditions

Treatments: Device: Radiofrequency device; Device: Combined energy devices; Device: Intense pulsed light.; Device: Radiofrequency microneedling device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06111482

EUN-PL01-2023

Details and patient eligibility

About

The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

IPL only

Experimental group

Description:

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.

Treatment:

Device: Intense pulsed light.

RF Microneedling Only

Experimental group

Description:

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.

Treatment:

Device: Radiofrequency microneedling device

RF Only

Experimental group

Description:

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.

Treatment:

Device: Radiofrequency device

Combination

Experimental group

Description:

Group D will receive combination treatments and will be treated with 2 or more of the study devices.

Treatment:

Device: Radiofrequency microneedling device

Device: Radiofrequency device

Device: Combined energy devices

Device: Intense pulsed light.