RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-09-28

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06111482

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.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Jamie Trimper

CONTACT

9782564200

jamie.trimper@cynosure.com

Principal Investigator

Sean Doherty

PRINCIPAL_INVESTIGATOR

Cynosure, LLC

Study Locations (Sites)

Cynosure

Westford, Massachusetts, 01886

United States

Collaborators and Investigators

Sponsor: Cynosure, Inc.

Sean Doherty, PRINCIPAL_INVESTIGATOR, Cynosure, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-28

Study Completion Date2025-02

Study Record Updates

Study Start Date2023-09-28

Study Completion Date2025-02

Terms related to this study

Additional Relevant MeSH Terms

Dermatologic Conditions