Trial Outcomes & Findings for Radio-Frequency Microneedling Device (NCT NCT06228144)
NCT ID: NCT06228144
Last Updated: 2026-04-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
5,15,30, and 45 seconds
Results posted on
2026-04-29
Participant Flow
Participant milestones
| Measure |
Treatment
6 healthy subjects complete Phase 1 receiving treatment of the microneedling insertion procedure (without the use of RF energy) and experimental EC device.
12 healthy subjects complete Phase 2 receiving treatment of the microneedling insertion procedure (with the use of RF energy) and experimental EC device. Phase 2 was not enrolled.
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).
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.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radio-Frequency Microneedling Device
Baseline characteristics by cohort
| Measure |
Treatment
n=6 Participants
6 healthy subjects complete Phase 1 receiving treatment of the microneedling insertion procedure (without the use of RF energy) and experimental EC device.
12 healthy subjects complete Phase 2 receiving treatment of the microneedling insertion procedure (with the use of RF energy) and experimental EC 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).
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Microneedling Pain Score (no cooling)
|
2.4 units on a scale
STANDARD_DEVIATION 1.1 • n=9 Participants
|
PRIMARY outcome
Timeframe: 5,15,30, and 45 secondsSubjects 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.
Outcome measures
| Measure |
Treatment
n=6 Participants
6 healthy subjects complete Phase 1 receiving treatment of the microneedling insertion procedure (without the use of RF energy) and experimental EC device.
|
|---|---|
|
Pain Score During Microneedling (With Cooling)
5 seconds of precooling
|
2.7 score on a scale
Standard Deviation 1.0
|
|
Pain Score During Microneedling (With Cooling)
15 seconds of precooling
|
2.2 score on a scale
Standard Deviation 1.0
|
|
Pain Score During Microneedling (With Cooling)
30 seconds of precooling
|
1.9 score on a scale
Standard Deviation 1.1
|
|
Pain Score During Microneedling (With Cooling)
45 seconds of precooling
|
1.7 score on a scale
Standard Deviation 1.0
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dieter Manstein, MD, PhD
Massachusetts General Hospital
Phone: 617-726-4454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place