Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

Cynosure, Inc.79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Subject Satisfaction

Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.

Time frame: 30 day follow up

Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.