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NCT06228144 · ClinicalTrials.gov registry record · NA
Radio-Frequency Microneedling Device
A NA study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT06228144: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT06228144 is a NA study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06228144, a NA study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DEVICE Candela Profound System with Dermal Handpiece
- DEVICE Experimental Dermal Cooling Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2024-04-12 |
| Phase | NA |
Why NCT06228144 stopped before completion
NCT06228144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Candela Profound System with Dermal Handpiece is the first listed.
NCT06228144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06228144 about?
NCT06228144 is a clinical study titled "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 dur...
What is the current status of trial NCT06228144?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2024-01-31. Estimated completion is 2024-04-12.
What interventions are being tested in trial NCT06228144?
The interventions under investigation include: Candela Profound System with Dermal Handpiece (DEVICE), Experimental Dermal Cooling Device (DEVICE).
Who is sponsoring clinical trial NCT06228144?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06228144's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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