Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device

• ClinicalTrials.gov Identifier: NCT05254210
• Recruitment Status: Completed
• First Posted: February 24, 2022
• Last Update Posted: July 20, 2022
• Sponsor: Cynosure, Inc.
• Information provided by (Responsible Party): Cynosure, Inc.

Study Description

Brief Summary:

The intended use of the Potenza™ device is to collect clinical data for brow lifting and/or treatment of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Condition or disease	Intervention/treatment	Phase
Wrinkles; Fine Lines; Crepey Skin; Acne Scars; Active Acne; Enlarged Pores; Loose Skin	Device: RF Device (Potenza™)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device
• Actual Study Start Date: September 13, 2021
• Actual Primary Completion Date: May 17, 2022
• Actual Study Completion Date: May 17, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment with RF Device; Subjects may receive up to 3 treatments with the RF device if they are willing to receive treatment for brow lifting and/or present with conditions such as, but not limited to; wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, loose skin on the face, neck and/or body	Device: RF Device (Potenza™); Test spots may be performed prior to the first treatment. Following test spots, for the treatment, the tip will be placed in contact with the skin. Parameters may be adjusted throughout the treatment and will determined by the Clinician.

Outcome Measures

Primary Outcome Measures :

1. Evaluation of baseline photographs compared to post treatment images [ Time Frame: 30 day follow up ]
   Photographs will be evaluated at the baseline and the 30 day follow up. The number of photographs with improvement (based on changes in the skin) from baseline to follow up images will be reported.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• A healthy, non-smoking male or female between the age of 18-60 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 3 months 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 investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Cautionary Criteria:

• The subject is prone to fever blisters: they should receive a prophylactic antiviral medication regimen prior to treatment.
• The subject has lesions in the treatment area that have not been evaluated and diagnosed: they should be evaluated prior to the treatment day.
• The subject has malignant disease (excluding skin malignancies).
• The subject has used retinoids in the last seven days in the area to be treated: retinoids can create erythema and cause the skin to become heat sensitive.
• The subject has used any chemical peels in the last two to three months in the treatment area: subjects should wait until any remaining erythema or side effects have resolved.
• The subject has tattoos, permanent makeup, and permanent brows in the treatment area: caution must be used. (The ink used in these applications is unregulated and may have metallic components.)
• The subject has a neuropathic disorder, impaired skin sensation or diabetic neuropathy.
• The subject has received fillers or neurotoxin injections: subjects should wait two weeks before receiving a Potenza treatment.

Contacts and Locations

Locations

United States, California

Profiles Beverly Hills

West Hollywood, California, United States, 90069

Sponsors and Collaborators

Cynosure, Inc.

Investigators

• Study Director: Jennifer Civiok; Director of Clinical Research

More Information

• Responsible Party: Cynosure, Inc.
• ClinicalTrials.gov Identifier: NCT05254210
• Other Study ID Numbers: CYN20-RF-MN-PROFILES
• First Posted: February 24, 2022
• Last Update Posted: July 20, 2022
• Last Verified: July 2022

• 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

Additional relevant MeSH terms:

Cutis Laxa; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Connective Tissue Diseases