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Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin

Primary Purpose

Dermatologic Conditions

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potenza
Morpheus
Sponsored by
Cynosure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatologic Conditions

Eligibility Criteria

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

Inclusion Criteria: A healthy male or female between the age of 18-65 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 received fillers or neurotoxin injections within the past 3 months. 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 keloid formation propensity. Subjects with electronic implants such as cardiac defibrillator. It may interfere with the 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 confuse study results or may interfere significantly with the subject's participation

Sites / Locations

  • Cynosure, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A- Split face

Group B- none split face

Arm Description

Group A will receive split face treatments with the Potenza and Morpheus. Randomization will not be used for enrolling subjects to a group but will be used for Group A to determine which side of the face will receive which device.

Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus.

Outcomes

Primary Outcome Measures

Maximum pain reported during treatment.
The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain).

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
September 6, 2023
Sponsor
Cynosure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06023303
Brief Title
Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin
Official Title
Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (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 Radiofrequency microneedling devices (Potenza and Morpheus) 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 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2 groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatologic Conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be treated with the Potenza device on one side of the face and will receive treatment with Morpheus device on the other side of the face.
Masking
Participant
Masking Description
Subjects do not know which side of the face will be treated with either of the devices.
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A- Split face
Arm Type
Experimental
Arm Description
Group A will receive split face treatments with the Potenza and Morpheus. Randomization will not be used for enrolling subjects to a group but will be used for Group A to determine which side of the face will receive which device.
Arm Title
Group B- none split face
Arm Type
Experimental
Arm Description
Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus.
Intervention Type
Device
Intervention Name(s)
Potenza
Intervention Description
The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.
Intervention Type
Device
Intervention Name(s)
Morpheus
Intervention Description
The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.
Primary Outcome Measure Information:
Title
Maximum pain reported during treatment.
Description
The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain).
Time Frame
procedure (during device treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A healthy male or female between the age of 18-65 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 received fillers or neurotoxin injections within the past 3 months. 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 keloid formation propensity. Subjects with electronic implants such as cardiac defibrillator. It may interfere with the 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 confuse study results or may interfere significantly with the subject's participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Doherty
Organizational Affiliation
Cynosure, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cynosure, Inc
City
Westford
State/Province
Massachusetts
ZIP/Postal Code
01886
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin

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