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

Launched by CYNOSURE, INC. · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying different energy-based devices to see how safe and effective they are for treating various skin conditions that people may want to improve. The researchers are looking for healthy adults aged 22 and older who are willing to receive at least one treatment with these devices. Participants must also agree not to have any other procedures in the same area of their skin during the study and be able to attend all scheduled visits.

If you decide to participate, you can expect to receive treatment using one of the study devices, and you’ll need to follow some guidelines to ensure your safety and the success of the study. For example, women who are pregnant, breastfeeding, or planning to become pregnant during the study cannot participate. Additionally, other health conditions or recent treatments might also exclude some individuals from joining. It's important to read all the details carefully and discuss any questions or concerns with the study team before deciding to take part.

Gender

ALL

Eligibility criteria

• 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