Radio-Frequency Microneedling Device (RFS)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- MGH Clinical Unit for Research Trials & Outcomes in Skin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Treatment
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. |
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).
The experimental dermal cooling device is intended to facilitate pain management during the Profound RF microneedling treatment to the treatment area of the leg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Score During Microneedling (With Cooling)
Time Frame: 5,15,30, and 45 seconds
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dieter Manstein, MD, PhD, Massachusetts General Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021P001833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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