Trial Outcomes & Findings for Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction (NCT NCT03285581)
NCT ID: NCT03285581
Last Updated: 2023-09-13
Results Overview
GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
12 weeks post-final treatment
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Arm-1
Subject(s) will receive RF treatments
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction
Baseline characteristics by cohort
| Measure |
truSculpt RF
n=39 Participants
Subject will receive RF treatments
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-final treatmentGAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes
Outcome measures
| Measure |
truSculpt RF
n=25 Participants
Subject will receive RF treatments
|
|---|---|
|
Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)
|
1.04 score on a scale
Standard Deviation 0.45
|
Adverse Events
truSculpt RF
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
truSculpt RF
n=39 participants at risk
Subjects will receive RF treatments
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
100.0%
39/39 • 12 weeks post final treatment, up to 7 months
|
|
Skin and subcutaneous tissue disorders
Edema
|
76.9%
30/39 • 12 weeks post final treatment, up to 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place