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TERMINATED
NCT06228144
NA

Radio-Frequency Microneedling Device

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-01-31

Completion Date

2024-04-12

Last Updated

2026-04-29

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, United States