Stopped: Phase 1 of the study was completed. The PI decided not to proceed with Phase 2 of the study because redesign of cooling applicator was necessary to provide better alignment of cooling element with RF probes.
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).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pain Score During Microneedling (With Cooling)
Timeframe: 5,15,30, and 45 seconds