Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging

NCT05388604 | Completed FDA Device

• 1 other identifier: MD-PM01-2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

The intended use of the radiofrequency and microneedling devices used in this study is to assess the efficacy and safety of paired treatment for the treatment of facial aging.

Conditions

Wrinkle; Photoaging; Dyschromia

Outcome Measures

Primary Outcomes (2)

• Percent of Photos Identified Correctly of 30 Day Follow Up vs. Baseline

  The percent of correctly identified photographs (when comparing baseline photos vs. 30 day follow up photos) will be reported.

  30 day follow up

• Percent of Photos Identified Correctly of 90 Day Follow Up vs. Baseline

  The percent of correctly identified photographs (when comparing baseline photos vs. 90 day follow up photos) will be reported.

  90 day follow up

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects are to be treated with the RF device, followed by the microneedling device. Parameters may be adjusted throughout the treatment and will determined by the Clinician. Subjects will receive up to 4 treatments, spaced approximately 4 weeks apart.

Device: RF device; Device: Microneedling device

Interventions

RF device DEVICE

The entire defined treatment area will then be treated by delivering adjacent pulses with minimal overlap of 10% or less. Parameters may be adjusted throughout the treatment in order to increase subject comfort.

Treatment

Microneedling device DEVICE

Test spots may be performed prior to the first treatment. Test spots may be performed prior to the first treatment. It will follow a similar procedure to treatment but only in an inconspicuous place, such as behind the ear, in an area no larger than 2in x 2in. The tip will be placed in contact with the skin, and parameters may be adjusted throughout the treatment and will determined by the Clinician.

Treatment

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy male or female between the age of 40 - 65 years old.
• Diagnosed with clinically evident moderate wrinkles and/or moderate photoaging, including but not limited to dyschromia, and willing to undergo treatments with the study devices.
• 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.

You may not qualify if:

• The subject 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 hypersensitive to light in the near infrared wavelength region.
• The subject is taking medication which is known to increase sensitivity to sunlight.
• The subject has a seizure disorders triggered by light.
• The subject is taking or have taken oral isotretinoin, such as Accutane®, within the last six months.
• The subject has an active localized or systemic infection, or an open wound in area being treated.
• The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
• The subject has active herpes simplex in the area being treated.
• The subject is receiving or have received gold therapy.
• The subject has a pacemaker.
• 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 such as 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.
• The subject is allergic to gold.
• The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area or a neuropathic disorder.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (3)

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Study Officials

• Jennifer Civiok

  Director of Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: June 15, 2022
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)