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CompletedNCT06023303Updated Jan 9, 2024

Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin

An interventional study of Potenza and Morpheus in Dermatologic Conditions, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 1 month ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Read the detailed description

Up to 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2 groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).

02

Conditions studied

  • Dermatologic Conditions

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03

In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.

This study's enrollment of 8 is below the median of 60 across 372 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A healthy male or female between the age of 18-65 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

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 1 month prior to entering this study.
  • The subject has received fillers or neurotoxin injections within the past 3 months.
  • 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 keloid formation propensity.
  • Subjects with electronic implants such as cardiac defibrillator. It may interfere with the 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 confuse study results or may interfere significantly with the subject's participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Group A- Split face

    Group A will receive split face treatments with the Potenza and Morpheus. Randomization will not be used for enrolling subjects to a group but will be used for Group A to determine which side of the face will receive which device.

    Device: Potenza · Device: Morpheus

  • Experimental
    Group B- none split face

    Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus.

    Device: Potenza · Device: Morpheus

Interventions

  • DevicePotenza

    The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.

  • DeviceMorpheus

    The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.

06

What researchers measure

Primary outcomes

  1. Maximum pain reported during treatment.

    The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain).

    Time frame: procedure (during device treatment)

07

Study locations

1 site
  • Cynosure, Inc
    Westford, Massachusetts 01886, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06023303
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Sep 5, 2023
Start date
Jun 21, 2023
Primary completion
Aug 10, 2023
Completion
Aug 10, 2023
Last update
Jan 9, 2024

Study contacts

Sean Doherty
principal investigator · Cynosure, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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