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

NCT05096247 | Completed Results FDA Device

• 1 other identifier: 7027-PM01-2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Wrinkle; Benign Pigmented Lesions; Benign Vascular Lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment with RF Device

EXPERIMENTAL

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

Treatment with IPL and RF Device

EXPERIMENTAL

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; Device: Icon

Interventions

TempSure DEVICE

This device is an RF device.

Treatment with IPL and RF Device; Treatment with RF Device

Icon DEVICE

This device works with IPL (Intense Pulsed Light) handpieces.

Treatment with IPL and RF Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (3)

Cynosure

Westford, Massachusetts, 01886, United States

Location

Excellent Vision

Portsmouth, New Hampshire, 03801, United States

Location

Saluja Cosmetic and Laser Center

Huntersville, North Carolina, 28078, United States

Location

Related Publications (1)

• 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.

  PMID: 31896400 RESULT

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

(978) 256-4200

Study Officials

• Jennifer Civiok

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One site will enroll patients to be treated with the the RF device, and the other site will enroll patients to be treated with the RF device and the Intense Pulsed Light (IPL) laser.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: September 3, 2021
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)