Clinical trial NCT05097157: Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
Official title: Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Fine Lines
Crepey Skin
Acne Scars
Acne
Enlarged Pores
Stretch Marks
Loose Skin
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Subject Satisfaction
timeFrame: 30 day follow up
measure: Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
timeFrame: 30 day follow up
measure: Subject Satisfaction
timeFrame: 90 day follow up
measure: Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
timeFrame: 90 day follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Hunt Valley
country: United States
facility: Maryland Dermatology Laser, Skin, & Vein Institute, LLC.
state: Maryland
city: Westford
country: United States
facility: Cynosure
state: Massachusetts
city: Virginia Beach
country: United States
facility: McDaniel Institute of Anti-Aging Research
state: Virginia
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
affiliation: Cynosure, Inc.
name: Sean Doherty
role: PRINCIPAL_INVESTIGATOR
affiliation: Maryland Dermatology Laser, Skin, & Vein Institute, LLC
name: Robert Weiss
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Dermatology and Laser Surgery
name: Emil Tanghetti
role: PRINCIPAL_INVESTIGATOR
affiliation: McDaniel Institute of Anti-Aging Research
name: David McDaniel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.