search
Back to results

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions

Primary Purpose

Wrinkle, Fine Lines, Crepey Skin

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RadioFrequency Microneedling Device
Sponsored by
Cynosure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrinkle

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A healthy, non-smoking male or female between the age of 22-65 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 1 month prior to entering this study. The subject has a pacemaker. The subject had previous use of gold thread skin rejuvenation. The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated). The subject has a metal implant that interferes with the transmission of energy to the electrical field. The subject has any embedded electronic devices that give or receive a signal. The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant. The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area. The subject is allergic to gold. The subject has an unrealistic expectation of the results: this is not plastic surgery, and all subjects should be fully informed of the treatment's expected results. The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area. The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated: this treatment will be ineffective. The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle. The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti- inflammatories or anticoagulants. The subject has a history of bleeding coagulopathies. The subject is allergic to topical anesthetic. The subject has any of the following conditions: Diabetes Epilepsy Autoimmune disease Herpes simplex HIV Hypertension Dermatitis The subject has keloid formation propensity. 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 investigator's opinion may put the subject at significant risk, may confound study results or may interfere. significantly with the subject's participation.

Sites / Locations

  • Cynosure, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

General Treatment

Split-face treatment

Arm Description

Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins.

Subjects will receive split-face treatments where each side of the face may be treated with different tips.

Outcomes

Primary Outcome Measures

% of subjects satisfied with treatments.
% of subjects satisfied with the treatment will the reported at the 30 days follow up.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
September 6, 2023
Sponsor
Cynosure, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05987319
Brief Title
Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions
Official Title
Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
Detailed Description
Up to 12 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups. Group A will receive treatments on the face, neck, and/or body. Group B will receive split-face treatments where each side of the face may be treated with different tips. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkle, Fine Lines, Crepey Skin, Acne Scars, Active Acne, Enlarged Pores, Stretch Mark, Loose Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General Treatment
Arm Type
Experimental
Arm Description
Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins.
Arm Title
Split-face treatment
Arm Type
Experimental
Arm Description
Subjects will receive split-face treatments where each side of the face may be treated with different tips.
Intervention Type
Device
Intervention Name(s)
RadioFrequency Microneedling Device
Intervention Description
RadioFrequency device will be used for the treatment of dermatologic conditions.
Primary Outcome Measure Information:
Title
% of subjects satisfied with treatments.
Description
% of subjects satisfied with the treatment will the reported at the 30 days follow up.
Time Frame
30 days post last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A healthy, non-smoking male or female between the age of 22-65 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 1 month prior to entering this study. The subject has a pacemaker. The subject had previous use of gold thread skin rejuvenation. The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated). The subject has a metal implant that interferes with the transmission of energy to the electrical field. The subject has any embedded electronic devices that give or receive a signal. The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant. The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area. The subject is allergic to gold. The subject has an unrealistic expectation of the results: this is not plastic surgery, and all subjects should be fully informed of the treatment's expected results. The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area. The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated: this treatment will be ineffective. The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle. The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti- inflammatories or anticoagulants. The subject has a history of bleeding coagulopathies. The subject is allergic to topical anesthetic. The subject has any of the following conditions: Diabetes Epilepsy Autoimmune disease Herpes simplex HIV Hypertension Dermatitis The subject has keloid formation propensity. 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 investigator's opinion may put the subject at significant risk, may confound study results or may interfere. significantly with the subject's participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Trimper
Phone
9782564200
Email
jamie.trimper@cynosure.com
Facility Information:
Facility Name
Cynosure, Inc.
City
Westford
State/Province
Massachusetts
ZIP/Postal Code
01886
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Doherty
First Name & Middle Initial & Last Name & Degree
Sean Doherty

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions

We'll reach out to this number within 24 hrs