NCT06111482

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

October 20, 2023

Last Update Submit

October 26, 2023

Conditions

Dermatologic Conditions

Outcome Measures

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). This pain is recorded during when the patient is actively treated (when the patient comes in and receives a treatment from the device).

    procedure (during device treatment)]

Study Arms (4)

IPL only

EXPERIMENTAL

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.

Device: Intense pulsed light.

RF Microneedling Only

EXPERIMENTAL

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.

Device: Radiofrequency microneedling device

RF Only

EXPERIMENTAL

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.

Device: Radiofrequency device

Combination

EXPERIMENTAL

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

Device: Intense pulsed light.Device: Radiofrequency microneedling deviceDevice: Radiofrequency deviceDevice: Combined energy devices

Interventions

Intense pulsed light.DEVICE

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.

CombinationIPL only
Radiofrequency microneedling deviceDEVICE

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.

CombinationRF Microneedling Only
Radiofrequency deviceDEVICE

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.

CombinationRF Only
Combined energy devicesDEVICE

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.

Combination

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cynosure

Westford, Massachusetts, 01886, United States

RECRUITING

MeSH Terms

Interventions

Intense Pulsed Light Therapy

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Officials

  • Sean Doherty

    Cynosure, LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Trimper

CONTACT

9782564200jamie.trimper@cynosure.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be treated with an intended pulsed light device. Subjects 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 or a similar microneedling device. Randomization will not be used as the group the subject will be assigned to will be determined based on dermatologic condition the subject presents with and this will be determined by the Investigator.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

November 1, 2023

Study Start

September 28, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

US(1)