Status:
UNKNOWN
Clinical Study to Evaluate Different Energy-based Devices for Aesthetic Treatments.
Lead Sponsor:
Cynosure, Inc.
Conditions:
Dermatologic Conditions
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06111482
Start Date
September 28 2023
End Date
February 1 2025
Last Update
November 1 2023
Active Locations (1)
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1
Cynosure
Westford, Massachusetts, United States, 01886