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Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05097157
Recruitment Status : Completed
First Posted : October 28, 2021
Results First Posted : June 9, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

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.

Condition or disease Intervention/treatment Phase
Wrinkle Fine Lines Crepey Skin Acne Scars Acne Enlarged Pores Stretch Marks Loose Skin Device: Potenza Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions
Actual Study Start Date : September 3, 2019
Actual Primary Completion Date : April 12, 2021
Actual Study Completion Date : June 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arm Intervention/treatment
Experimental: Treatment with Device
Subjects received up to 5 treatments with the device, spaced 4 weeks apart.
Device: 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.




Primary Outcome Measures :
  1. Subject Satisfaction [ Time Frame: 30 day follow up ]
    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.

  2. Global Aesthetic Improvement Scale Assessment (GAIS) Assessment [ Time Frame: 30 day follow up ]
    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.

  3. Subject Satisfaction [ Time Frame: 90 day follow up ]
    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.

  4. Global Aesthetic Improvement Scale Assessment (GAIS) Assessment [ Time Frame: 90 day follow up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05097157


Locations
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United States, California
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
United States, Maryland
Maryland Dermatology Laser, Skin, & Vein Institute, LLC.
Hunt Valley, Maryland, United States, 21030
United States, Massachusetts
Cynosure
Westford, Massachusetts, United States, 01886
United States, Virginia
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Jennifer Civiok Cynosure, Inc.
Principal Investigator: Sean Doherty Cynosure, Inc.
Principal Investigator: Robert Weiss Maryland Dermatology Laser, Skin, & Vein Institute, LLC
Principal Investigator: Emil Tanghetti Center for Dermatology and Laser Surgery
Principal Investigator: David McDaniel McDaniel Institute of Anti-Aging Research
  Study Documents (Full-Text)

Documents provided by Cynosure, Inc.:
Publications of Results:
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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT05097157    
Other Study ID Numbers: CYN19-RF-MN-01
First Posted: October 28, 2021    Key Record Dates
Results First Posted: June 9, 2022
Last Update Posted: June 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Skin Diseases
Striae Distensae
Skin Manifestations