Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging

Completed · Not applicable

Conditions studied: Wrinkle, Photoaging, Dyschromia

In brief

The intended use of the radiofrequency and microneedling devices used in this study is to assess the efficacy and safety of paired treatment for the treatment of facial aging.

Key facts

Study ID

NCT05388604

Run by

Cynosure, Inc.

People needed

42

Starts

2022-06-15

Expected to finish

2023-08-29

Last updated by the study team

2023-10-18

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A healthy male or female between the age of 40 - 65 years old.
• Diagnosed with clinically evident moderate wrinkles and/or moderate photoaging, including but not limited to dyschromia, and willing to undergo treatments with the study devices.
• Understands and accepts obligation not to receive any other procedures on 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.

You may not qualify if…

• The subject is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
• The subject is hypersensitive to light in the near infrared wavelength region.
• The subject is taking medication which is known to increase sensitivity to sunlight.
• The subject has a seizure disorders triggered by light.
• The subject is taking or have taken oral isotretinoin, such as Accutane®, within the last six months.
• The subject has an active localized or systemic infection, or an open wound in area being treated.
• The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
• The subject has active herpes simplex in the area being treated.
• The subject is receiving or have received gold therapy.
• The subject has a pacemaker.
• The subject has a metal implant that interferes with the transmission of energy to the electrical field.
• The subject has any embedded electronic devices that give or receive a signal 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.
• The subject is allergic to adhesives such as glues on medical tape.
• The subject is allergic to gold.
• The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area or a neuropathic disorder.
• The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated
• The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti-inflammatories or anticoagulants.
• The subject has a history of bleeding coagulopathies.
• The subject is allergic to topical anesthetic.
• The subject has any of the following conditions:
• Uncontrolled diabetes
• Epilepsy
• Autoimmune disease
• HIV
• Uncontrolled hypertension

Where it is running

• Center for Dermatology and Laser Surgery — Sacramento, California, United States
• New Jersey Plastic Surgery — Montclair, New Jersey, United States
• Laser & Skin Surgery Center of New York — New York, New York, United States

Full record on ClinicalTrials.gov

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