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WrinkleNCT05388604

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

A study testing RF device and Microneedling device in people with Wrinkle and Photoaging, run by Cynosure, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Wrinkle, Photoaging, Dyschromia
What is being tested?
RF device and Microneedling device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
3 sitesUnited States
Study dates
15 Jun 2022to 29 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 37Show fewer
  • 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.
  • The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated
  • 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:
  • Uncontrolled diabetes
  • Epilepsy
  • Autoimmune disease
  • HIV
  • Uncontrolled hypertension
  • The subject has keloid formation propensity.
  • 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 the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
  • 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 has had unprotected sun exposure within four weeks of treatment, including the use of tanning beds or tanning products, such as creams, lotions, and sprays.
  • The subject has a history of immunosuppression/immune deficiency or an auto-immune disorder.
  • The subject is taking medications that alter the wound-healing response or evidence of compromised wound healing.
  • The subject has a history of skin cancer or suspicious lesions in the treatment area.
  • The subject has used retinoids in the last seven days in the area to be treated.
  • The subject has used any chemical peels in the last three months in the treatment area.
  • The subject has tattoos, permanent makeup, and permanent brows in the treatment area.
  • The subject has received fillers or neurotoxin injections in the last two weeks.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • New Jersey Plastic Surgery

    Montclair, New Jersey, 07042

  • Laser & Skin Surgery Center of New York

    New York, New York, 10016

  • Center for Dermatology and Laser Surgery

    Sacramento, California, 95819

Other trials in United States

About this study

Official title: Prospective Clinical Study To Evaluate The Efficacy And Safety Of Paired Treatment With A Picosecond 755nm Alexandrite Laser With Focused Lens Array And Radiofrequency Microneedling For Facial Aging

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.

Read the detailed description

Subjects are to be enrolled in this clinical study if they are a healthy male or female 40 - 65 years of age. Up to 35 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face.

Being tested
RF device, Microneedling device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RF deviceDevice

    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.

  • Microneedling deviceDevice

    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.

Study groups in NCT05388604
Study groupRoleWhat they receive
TreatmentExperimentalSubjects 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.
Receives: Device: RF device; Device: Microneedling device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 day follow up

  2. 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.

    Measured: 90 day follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start15 Jun 2022
  3. Primary completion29 Aug 2023
  4. Study completion29 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388604
Sponsor's protocol ID
MD-PM01-2021
Status last verified
Oct 2023
First submitted
19 May 2022
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing RF device and Microneedling device in people with Wrinkle and Photoaging, run by Cynosure, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Photos Identified Correctly of 30 Day Follow Up vs. Baseline (time frame: 30 day follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05388604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

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