Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions

NCT05987319 | Recruiting FDA Device

• 1 other identifier: CYN20-RF-MN-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Conditions

Wrinkle; Fine Lines; Crepey Skin; Acne Scars; Active Acne; Enlarged Pores; Stretch Mark; Loose Skin

Outcome Measures

Primary Outcomes (1)

• % of subjects satisfied with treatments.

  % of subjects satisfied with the treatment will the reported at the 30 days follow up.

  30 days post last treatment

Study Arms (2)

General Treatment

EXPERIMENTAL

Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins.

Device: RadioFrequency Microneedling Device

Split-face treatment

EXPERIMENTAL

Subjects will receive split-face treatments where each side of the face may be treated with different tips.

Device: RadioFrequency Microneedling Device

Interventions

RadioFrequency Microneedling Device DEVICE

RadioFrequency device will be used for the treatment of dermatologic conditions.

General Treatment; Split-face treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy, non-smoking male or female between the age of 22-65 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 1 month 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)

Cynosure, Inc.

Westford, Massachusetts, 01886, United States

RECRUITING

MeSH Terms

Conditions

Striae Distensae; Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Jamie Trimper

CONTACT

9782564200; jamie.trimper@cynosure.com

Study Design

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

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: July 24, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)