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

Not Applicable

Completed

• Conditions: Wrinkle; Benign Pigmented Lesions; Benign Vascular Lesions
• Interventions: Device: TempSure; Device: Icon

• Registration Number: NCT05096247
• Lead Sponsor: Cynosure, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-03
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Results First Submitted: 2023-10-17
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Results First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with RF Device	TempSure	Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.
Treatment with IPL and RF Device	TempSure	Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.
Treatment with IPL and RF Device	Icon	Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Noticed Improvement	12 week follow up	Subjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported.

Trial Locations

Locations (3)

Cynosure; 🇺🇸 Westford, Massachusetts, United States

Excellent Vision; 🇺🇸 Portsmouth, New Hampshire, United States

Saluja Cosmetic and Laser Center; 🇺🇸 Huntersville, North Carolina, United States