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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096247
• Other study ID #: 7027-PM01-2021
• Status: Completed
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: September 13, 2022

Study information

• Verified date: November 2023
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Pigmented Lesions
• Wrinkle

Intervention

Device:
• TempSure
This device is an RF device.
• Icon
This device works with IPL (Intense Pulsed Light) handpieces.

Locations

Country	Name	City	State
United States	Saluja Cosmetic and Laser Center	Huntersville	North Carolina
United States	Excellent Vision	Portsmouth	New Hampshire
United States	Cynosure	Westford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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