Recruiting

Energy-based Devices

Sponsor:

Cynosure, Inc.

Code:

NCT06111482

Conditions

Dermatologic Conditions

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Intense pulsed light.

Radiofrequency microneedling device

Radiofrequency device

Combined energy devices

Study Details

Brief summary:

The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.

Conditions

Dermatologic Conditions

Study ID

NCT06111482

Start date

Sep 28, 2023

Status verified date

Oct, 2023

Completion date

Feb, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A healthy male or female 22 years of age or older.
  • Willing to undergo at least 1 treatment with the study device(s).
  • Understands and accepts obligation not to receive any other procedures in 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 female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
  • Takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
  • Is using systemic steroids (e.g., prednisone, dexamethasone) prior to or during the course of treatment.
  • Is receiving or has received gold therapy.
  • Is taking medications that alter the wound-healing response or has a history of healing problems.
  • Has an active localized or systemic infection, or an open wound in area being treated.
  • Has a significant systemic illness, such as lupus, or an illness localized in area being treated.
  • Has a seizure disorders triggered by light.
  • Has a history of skin photosensitivity disorders.
  • Has a history of hypertrophic scars or keloid formation.
  • Has a history of radiation therapy in area to be treated.
  • Received fillers or neurotoxin injections in the treatment area within the past 2 weeks.
  • Has had a chemical or mechanical epilation within the last six weeks.
  • 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 to entering this study.
  • Has any condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Radiofrequency Device Only:

  • Has a Pacemaker
  • Has any embedded electronic devices that give or receive a signal.
  • Has electronic implants, 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.
  • 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.
  • Has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
  • Is allergic to topical anesthetic

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IPL only

Group A will be treated with an intense pulsed light (IPL) device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar IPL device that is cleared for use by the FDA.

experimental: RF Microneedling Only

Group B will be treated with a radiofrequency (RF) microneedling device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF microneedling device that is cleared for use by the FDA.

experimental: RF Only

Group C will be treated with an RF device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF device that is cleared for use by the FDA.

experimental: Combination

Group D will receive combination treatments and will be treated with 2 or more of the study devices.

Interventions

Intense pulsed light.

The intense pulsed light (IPL) will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.

Radiofrequency microneedling device

The microneedling device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.

Radiofrequency device

The radio frequency device will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.

Combined energy devices

The combined energy devices will be used for treating unwanted dermatologic conditions which may be on multiple areas of the body such as, but not limited to, the face, décolletage, back, legs, arms, and hands.

Primary outcome measure

  • Maximum pain reported during treatment. [ Time Frame: procedure (during device treatment)] ]

Central Contacts and Locations

Central contacts

Jamie Trimper

9782564200jamie.trimper@cynosure.com

Locations

Cynosure

Recruiting

Westford, Massachusetts, United States, 01886

More Information

Sponsor

Cynosure, Inc.

Last update posted

Nov 1, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cynosure, Inc. on 2023-11-01.