Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Potenza

About this trial

This is an interventional treatment trial for Wrinkle

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Center for Dermatology and Laser Surgery
Maryland Dermatology Laser, Skin, & Vein Institute, LLC.
Cynosure
McDaniel Institute of Anti-Aging Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with Device

Arm Description

Subjects received up to 5 treatments with the device, spaced 4 weeks apart.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05097157

First Posted

October 15, 2021

Last Updated

May 18, 2022

Sponsor

Cynosure, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05097157

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

September 3, 2019 (Actual)

Primary Completion Date

April 12, 2021 (Actual)

Study Completion Date

June 21, 2021 (Actual)

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

Data Monitoring Committee

No

5. Study Description

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.

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, Acne, Enlarged Pores, Stretch Marks, Loose Skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with Device

Arm Type

Experimental

Arm Description

Subjects received up to 5 treatments with the device, spaced 4 weeks apart.

Intervention Type

Device

Intervention Name(s)

Potenza

Intervention Description

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 Measure Information:

Title

Subject Satisfaction

Description

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.

Time Frame

30 day follow up

Title

Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

Description

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.

Time Frame

30 day follow up

Title

Subject Satisfaction

Description

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.

Time Frame

90 day follow up

Title

Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

Description

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.

Time Frame

90 day follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials: