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WrinklesNCT05254210

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

A study testing RF Device (Potenza™) in people with Wrinkles and Fine Lines, run by Cynosure, Inc. at 1 site 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 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Wrinkles, Fine Lines, Crepey Skin
What is being tested?
RF Device (Potenza™)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
13 Sep 2021to 17 May 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Profiles Beverly Hills

    West Hollywood, California, 90069

Other trials in United States

About this study

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.

Being tested
RF Device (Potenza™)
Medical subject headings
Cutis Laxa

What participants receive

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

  • RF Device (Potenza™)Device

    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.

Study groups in NCT05254210
Study groupRoleWhat they receive
Treatment with RF DeviceExperimentalSubjects 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
Receives: Device: RF Device (Potenza™)

What is being measured

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

  1. Evaluation of Baseline Photographs Compared to Post Treatment Images

    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.

    Measured: 30 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 Feb 2022
  2. Study start13 Sep 2021
  3. Primary completion17 May 2022
  4. Study completion17 May 2022

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254210
Sponsor's protocol ID
CYN20-RF-MN-PROFILES
Status last verified
Jul 2023
First submitted
15 Feb 2022
Last updated
15 Aug 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

    PubMed 31896400

Questions about this trial

What is this clinical trial studying?

A study testing RF Device (Potenza™) in people with Wrinkles and Fine Lines, run by Cynosure, Inc. at 1 site 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 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of Baseline Photographs Compared to Post Treatment Images (time frame: 30 day follow up). 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 NCT05254210, which also lists 1 linked publication.

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 15 Aug 2023.

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