HealthyRFSNCT06228144

Radio-Frequency Microneedling Device

A study testing Candela Profound System with Dermal Handpiece and Experimental Dermal Cooling Device in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The specific aims of the study are as follows: Aim 1. Using the EC device, evaluate the cooling rate of in vivo tissue and the temperature profile of the tissue with various pre-cooling times (Phase 1). Aim 2. Read more about this study

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Candela Profound System with Dermal Handpiece and Experimental Dermal Cooling Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 31 Jan 2024to 12 Apr 2024
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
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Signed informed consent to participate in the study
Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
Fitzpatrick Skin Type I to III
Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment
Negative urine pregnancy test prior to treatment
General good health confirmed by medical history and skin examination of the area to be treated

Show all 10Show fewer

Willing to receive the Profound RF microneedling treatment
Willing to follow the treatment and post-treatment care instructions
Willing to have photographs and videos taken of the treated areas to be used de-identified in evaluations, publications and presentations
Subjects must be able to read and understand English.

Who cannot join

Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months
Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
Known allergy to lidocaine, 3 or more antibiotics, or glycerol.
Active malignancy or history of malignancy in the past 5 years.
Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Principal Investigator would interfere with the topical anesthetic, treatment or healing process).

Show all 25Show fewer

Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion)
Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medication.
Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
History of significant lymphatic drainage problems.
History of cancer which required lymph node biopsy or dissection.
Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course.
History of keloid scarring, abnormal wound healing, forming marked post-inflammatory hyper or hypopigmentation, and /or prone to bruising.
History of epidermal or dermal disorders (particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitic disorders.
Use of isotretinoin (Accutane) within 6 months of treatment or during study.
Subject on systemic corticosteroid therapy 6 months prior to or during the study.
Dysplastic nevi in the area to be treated.
Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used.
Subjects with history of severe edema.
Subject is unable or unwilling to comply with the study requirements.
Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device.
Any other condition that would, in the professional opinion of the investigator, potentially affect the integrity of the data or would pose an unacceptable risk to the subject.
Known history of cold urticaria.
Fitzpatrick skin type IV - VI

Trial locations and contacts

1 site in 1 country.

United States1 site

MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Feasibility Study of a Novel Cooling Device for Pain Management During Treatment of Skin With Radio-Frequency Microneedling Device

The specific aims of the study are as follows:

Aim 1. Using the EC device, evaluate the cooling rate of in vivo tissue and the temperature profile of the tissue with various pre-cooling times (Phase 1).

Aim 2. Using the EC device, evaluate the cooling time that is required to provide analgesia during RF microneedling at different energies (Phase 2).

Aim 3. Evaluate the pain management capability of the EC device compared to the TEC device during RF microneedling when using topical anesthesia only (Phase 2).

Aim 4. Determine if the EC device can eliminate the need for tumescent anesthesia and/or topical anesthesia prior to RF microneedling (Phase 2).

Aim 5. Evaluate the operability and ease of use of the EC device for clinicians (Phase 2).

Read the detailed description

In this research study we want to learn more about an experimental cooling method, evaporative cooling (EC), compared to the currently used thermoelectric cooling (TEC) for pain management during radiofrequency (RF) microneedling treatments. This study will use the Profound® RF microneedling device, manufactured by Candela, with a dermal handpiece which will have the experimental cooling plate attachment.

We will recruit and screen up to 30 subjects with the goal of having 6 subjects complete Phase 1 and 12 subjects complete Phase 2 of the study. Phase 2 of the study was not enrolled.

Conditions: Healthy
Being tested: Candela Profound System with Dermal Handpiece, Experimental Dermal Cooling Device

What participants receive

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

Candela Profound System with Dermal HandpieceDevice
Candela Profound System with Dermal Handpiece will be applied to the treatment area of the leg (without use of RF energy in Phase 1; with use of RF energy in Phase 2).
Experimental Dermal Cooling DeviceDevice
The experimental dermal cooling device is intended to facilitate pain management during the Profound RF microneedling treatment to the treatment area of the leg.

Study groups in NCT06228144
Study group	Role	What they receive
Treatment	Experimental	6 healthy subjects complete Phase 1 receiving treatment of the microneedling insertion procedure (without the use of RF energy) and experimental EC device. 12 healthy subjects complete Phase 2 receiving treatment of the microneedling insertion procedure (with the use of RF energy) and experimental EC device. Phase 2 was not enrolled. Receives: Device: Candela Profound System with Dermal Handpiece; Device: Experimental Dermal Cooling Device

What is being measured

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

Pain Score During Microneedling (With Cooling)
Subjects reported their pain levels during microneedling treatment after a varied amount of pre-cooling time.
Subjects reported pain score according to the Wong-Baker FACES Pain Rating Scale where pain is scored 0-10 with 0 being no pain and 10 being worst pain.
Measured: 5,15,30, and 45 seconds

Timeline

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

31 Jan 202412 Apr 2024

First posted29 Jan 2024
Study start31 Jan 2024
Primary completion12 Apr 2024
Study completion12 Apr 2024

Why it stopped: Phase 1 of the study was completed. The PI decided not to proceed with Phase 2 of the study because redesign of cooling applicator was necessary to provide better alignment of cooling element with RF probes.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06228144
Sponsor's protocol ID: 2021P001833
Acronym: RFS
Status last verified: Apr 2026
First submitted: 19 Jan 2024
Last updated: 29 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to make individual participant data (IPD) available to other researchers.

Publications

Alexiades-Armenakas M, Newman J, Willey A, Kilmer S, Goldberg D, Garden J, Berman D, Stridde B, Renton B, Berube D, Hantash BM. Prospective multicenter clinical trial of a minimally invasive temperature-controlled bipolar fractional radiofrequency system for rhytid and laxity treatment. Dermatol Surg. 2013 Feb;39(2):263-73. doi: 10.1111/dsu.12065. Epub 2012 Dec 28.
PubMed 23278964
Berube D, Renton B, Hantash BM. A predictive model of minimally invasive bipolar fractional radiofrequency skin treatment. Lasers Surg Med. 2009 Sep;41(7):473-8. doi: 10.1002/lsm.20794.
PubMed 19708063
Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.
PubMed 27327898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study of a Novel Cooling Device for Pain Management During Treatment of Skin With Radio-Frequency Microneedling Device
ClinicalTrials.gov ID: NCT06228144
Acronym / sponsor ID: RFS / 2021P001833
Conditions: Healthy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Phase 1 of the study was completed. The PI decided not to proceed with Phase 2 of the study because redesign of cooling applicator was necessary to provide better alignment of cooling element with RF probes.
Enrolment: 6 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 31 Jan 2024 (actual)
Primary completion: 12 Apr 2024 (actual)
Study completion: 12 Apr 2024 (actual)
First posted: 29 Jan 2024 (actual)
Results: Posted 29 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The specific aims of the study are as follows:

Aim 1. Using the EC device, evaluate the cooling rate of in vivo tissue and the temperature profile of the tissue with various pre-cooling times (Phase 1).

Aim 2. Using the EC device, evaluate the cooling time that is required to provide analgesia during RF microneedling at different energies (Phase 2).

Aim 3. Evaluate the pain management capability of the EC device compared to the TEC device during RF microneedling when using topical anesthesia only (Phase 2).

Aim 4. Determine if the EC device can eliminate the need for tumescent anesthesia and/or topical anesthesia prior to RF microneedling (Phase 2).

Aim 5. Evaluate the operability and ease of use of the EC device for clinicians (Phase 2).

Detailed description

We will recruit and screen up to 30 subjects with the goal of having 6 subjects complete Phase 1 and 12 subjects complete Phase 2 of the study. Phase 2 of the study was not enrolled.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: Candela Profound System with Dermal Handpiece, Device: Experimental Dermal Cooling Device6 healthy subjects complete Phase 1 receiving treatment of the microneedling insertion procedure (without the use of RF energy) and experimental EC device. 12 healthy subjects complete Phase 2 receiving treatment of the microneedling insertion procedure (with the use of RF energy) and experimental EC device. Phase 2 was not enrolled.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Signed informed consent to participate in the study
Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
Fitzpatrick Skin Type I to III
Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment
Negative urine pregnancy test prior to treatment

Key exclusion criteria (25 listed)

Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months
Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
Known allergy to lidocaine, 3 or more antibiotics, or glycerol.
Active malignancy or history of malignancy in the past 5 years.
Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Candela Profound System with Dermal HandpieceCandela Profound System with Dermal Handpiece will be applied to the treatment area of the leg (without use of RF energy in Phase 1; with use of RF energy in Phase 2).	Device	Treatment
Experimental Dermal Cooling DeviceThe experimental dermal cooling device is intended to facilitate pain management during the Profound RF microneedling treatment to the treatment area of the leg.	Device	Treatment

Primary outcome

Pain Score During Microneedling (With Cooling)
Time frame: 5,15,30, and 45 seconds
Subjects reported their pain levels during microneedling treatment after a varied amount of pre-cooling time. Subjects reported pain score according to the Wong-Baker FACES Pain Rating Scale where pain is scored 0-10 with 0 being no pain and 10 being worst pain.

Results and safety

Results posted to the registry on 29 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	6	6

Primary outcome: Pain Score During Microneedling (With Cooling)

Time frame: 5,15,30, and 45 seconds. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment n = 6
5 seconds of precooling	2.7 (1.0)
15 seconds of precooling	2.2 (1.0)
30 seconds of precooling	1.9 (1.1)
45 seconds of precooling	1.7 (1.0)

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23278964Alexiades-Armenakas M, Newman J, Willey A, Kilmer S, Goldberg D, Garden J, Berman D, Stridde B, Renton B, Berube D, Hantash BM. Prospective multicenter clinical trial of a minimally invasive temperature-controlled bipolar fractional radiofrequency system for rhytid and laxity treatment. Dermatol Surg. 2013 Feb;39(2):263-73. doi: 10.1111/dsu.12065. Epub 2012 Dec 28.
Background: PubMed 19708063Berube D, Renton B, Hantash BM. A predictive model of minimally invasive bipolar fractional radiofrequency skin treatment. Lasers Surg Med. 2009 Sep;41(7):473-8. doi: 10.1002/lsm.20794.
Background: PubMed 27327898Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.
Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dieter Manstein, MD, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Candela Profound System with Dermal Handpiece and Experimental Dermal Cooling Device in people with Healthy, run by Massachusetts General Hospital 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 10 inclusion and 25 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: stopped early, as of the sponsor's last update on 29 Apr 2026. 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 29 Apr 2026). 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?

Pain Score During Microneedling (With Cooling) (time frame: 5,15,30, and 45 seconds). 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 NCT06228144, which also lists 3 linked publications.

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 29 Apr 2026.