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).
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, United States
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.
Time frame: 5,15,30, and 45 seconds
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