Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

Acne Clinical Trial

Official title:

Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097157
• Other study ID #: CYN19-RF-MN-01
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: May 2022
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 21, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Scars
• Enlarged Pores
• Fine Lines
• Skin Diseases
• Stretch Marks
• Striae Distensae
• Wrinkle

Intervention

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.

Locations

Country	Name	City	State
United States	Maryland Dermatology Laser, Skin, & Vein Institute, LLC.	Hunt Valley	Maryland
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	McDaniel Institute of Anti-Aging Research	Virginia Beach	Virginia
United States	Cynosure	Westford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 day follow up
Primary	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.	30 day follow up
Primary	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.	90 day follow up
Primary	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.	90 day follow up