RECRUITING

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

Description

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

Study Overview

Study Details

Study overview

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

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

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

Condition
Dermatologic Conditions
Intervention / Treatment

-

Contacts and Locations

Westford

Cynosure, Westford, Massachusetts, United States, 01886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cynosure, Inc.,

Sean Doherty, PRINCIPAL_INVESTIGATOR, Cynosure, LLC

Study Record Dates

2025-02