Radio-Frequency Microneedling Device
NCT06228144 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-04-29
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
Interventions
- DEVICE
-
Candela Profound System with Dermal Handpiece
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).
- DEVICE
-
Experimental Dermal Cooling 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.
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Dieter Manstein, MD, PhD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-31
- Primary Completion
- 2024-04-12
- Completion
- 2024-04-12
- FDA Device
- Yes
Countries
- United States
Study Locations
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