Radio-Frequency Microneedling Device

NCT06228144 | Terminated Results FDA Device

• 1 other identifier: 2021P001833
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  5,15,30, and 45 seconds

Study Arms (1)

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.

Device: Candela Profound System with Dermal Handpiece; Device: Experimental Dermal Cooling Device

Interventions

Candela Profound System with Dermal Handpiece DEVICE

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).

Treatment

Experimental Dermal Cooling Device DEVICE

The experimental dermal cooling device is intended to facilitate pain management during the Profound RF microneedling treatment to the treatment area of the leg.

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• 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.

  PMID: 23278964 BACKGROUND

• 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.

  PMID: 19708063 BACKGROUND

• 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.

  PMID: 27327898 BACKGROUND

Results Point of Contact

• Title: Dieter Manstein, MD, PhD
• Organization: Massachusetts General Hospital

dmanstein@mgh.harvard.edu

617-726-4454

Study Officials

• Dieter Manstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: January 31, 2024
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)