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

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.

Study Overview

• Status: Completed
• Conditions: Benign Pigmented Lesions; Wrinkle; Benign Vascular Lesions
• Intervention / Treatment: Device: TempSure; Device: Icon

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Westford, Massachusetts, United States, 01886
      • Cynosure
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Excellent Vision
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Saluja Cosmetic and Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with RF Device; Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.	Device: TempSure; This device is an RF device.
Experimental: Treatment with IPL and RF Device; 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.	Device: TempSure; This device is an RF device.; Device: Icon; This device works with IPL (Intense Pulsed Light) handpieces.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Who Noticed Improvement	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.	12 week follow up

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Jennifer Civiok, Cynosure, Inc.

Publications and helpful links

General Publications

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 7027-PM01-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes