Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

NCT ID: NCT05097157

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-06-21

Brief Summary

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with Device

Subjects received up to 5 treatments with the device, spaced 4 weeks apart.

Group Type: EXPERIMENTAL

Potenza

Intervention Type: DEVICE

Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.

Interventions

Potenza

Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A healthy, non-smoking male or female between the age of 18-55 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.

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 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 6 months prior to entering this study.
• The subject has physical problems such as cardiovascular disorders.
• The subject has a pacemaker.
• The subject had previous use of gold thread skin rejuvenation.
• The subject has skin infections.
• The subject has any of the following conditions:

• Diabetes
• Epilepsy
• Acute disease
• Dermatitis
• Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Civiok

Role: STUDY_DIRECTOR

Cynosure, Inc.

Sean Doherty

Role: PRINCIPAL_INVESTIGATOR

Cynosure, Inc.

Robert Weiss

Role: PRINCIPAL_INVESTIGATOR

Maryland Dermatology Laser, Skin, & Vein Institute, LLC

Emil Tanghetti

Role: PRINCIPAL_INVESTIGATOR

Center for Dermatology and Laser Surgery

David McDaniel

Role: PRINCIPAL_INVESTIGATOR

McDaniel Institute of Anti-Aging Research

Locations

Center for Dermatology and Laser Surgery

Sacramento, California, United States

Maryland Dermatology Laser, Skin, & Vein Institute, LLC.

Hunt Valley, Maryland, United States

Cynosure

Westford, Massachusetts, United States

McDaniel Institute of Anti-Aging Research

Virginia Beach, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31896400 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CYN19-RF-MN-01

Identifier Type: -

Identifier Source: org_study_id