Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

Completed · Not applicable

Conditions studied: Wrinkle, Benign Pigmented Lesions, Benign Vascular Lesions

In brief

The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.

Key facts

Study ID

NCT05096247

Run by

Cynosure, Inc.

People needed

48

Starts

2021-09-03

Expected to finish

2022-09-13

Last updated by the study team

2023-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A healthy male or female 18 years of age or older.
• Agrees to be treated with the TempSure device.
• 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…

• 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 has a cut, wound, or infected skin on the area to be treated.
• The subject is on local, oral, or systemic anesthetic agents.
• The subject has nerve insensitivity to heat in the treatment area.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
• Exclusion Criteria for Icon Treatments Only:
• The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during the course of treatment.
• The subject has a medical condition or is receiving treatment that significantly compromise healing response.
• The subject has a history of light-induced seizures.
• The subject has a history of skin photosensitivity disorders.
• The subject has a history of hypertrophic scars or keloid formation.
• The subject has a history of radiation therapy in area to be treated.

Where it is running

• Cynosure — Westford, Massachusetts, United States
• Excellent Vision — Portsmouth, New Hampshire, United States
• Saluja Cosmetic and Laser Center — Huntersville, North Carolina, United States

Full record on ClinicalTrials.gov

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