Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device

NCT05254210 | Completed Results FDA Device

• 1 other identifier: CYN20-RF-MN-PROFILES
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The intended use of the Potenza™ device is to collect clinical data for brow lifting and/or treatment of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Conditions

Wrinkles; Fine Lines; Crepey Skin; Acne Scars; Active Acne; Enlarged Pores; Loose Skin

Outcome Measures

Primary Outcomes (1)

• Evaluation of Baseline Photographs Compared to Post Treatment Images

  Photographs will be evaluated at the baseline and the 30 day follow up. The number of photographs with improvement (based on changes in the skin) from baseline to follow up images will be reported.

  30 day follow up

Study Arms (1)

Treatment with RF Device

EXPERIMENTAL

Subjects may receive up to 3 treatments with the RF device if they are willing to receive treatment for brow lifting and/or present with conditions such as, but not limited to; wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, loose skin on the face, neck and/or body

Device: RF Device (Potenza™)

Interventions

RF Device (Potenza™) DEVICE

Test spots may be performed prior to the first treatment. Following test spots, for the treatment, the tip will be placed in contact with the skin. Parameters may be adjusted throughout the treatment and will determined by the Clinician.

Treatment with RF Device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy, non-smoking male or female between the age of 18-60 years old.
• Fitzpatrick skin type I to VI.
• 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 is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 3 months prior to entering this study.
• The subject has a pacemaker.
• The subject had previous use of gold thread skin rejuvenation.
• The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated).
• The subject has a metal implant that interferes with the transmission of energy to the electrical field.
• The subject has any embedded electronic devices that give or receive a signal.
• The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant.
• The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area.
• The subject is allergic to gold.
• The subject has an unrealistic expectation of the results: this is not plastic surgery, and all subjects should be fully informed of the treatment's expected results.
• The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
• The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated: this treatment will be ineffective.
• The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
• The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti-inflammatories or anticoagulants.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Profiles Beverly Hills

West Hollywood, California, 90069, 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

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

(978) 256-4200

Study Officials

• Jennifer Civiok

  Director of Clinical Research

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: September 13, 2021
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: August 15, 2023
• Results First Posted: August 15, 2023

Record last verified: 2023-07

Locations

US (1)