Trial Outcomes & Findings for Multi-Center, Clinical Evaluation of the Cutera Secret RF Device (NCT NCT03424161)

NCT ID: NCT03424161

Last Updated: 2023-09-15

Results Overview

Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: at 4 weeks follow-up and 12 weeks follow-up
• Results posted on: 2023-09-15

Participant Flow

Participant milestones

Measure	Secret RF Treatment with Secret RF for skin quality
Overall Study STARTED	27
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Center, Clinical Evaluation of the Cutera Secret RF Device

Baseline characteristics by cohort

Measure	Secret RF n=27 Participants Treatment with Secret RF for skin quality
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	22 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	9 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: at 4 weeks follow-up and 12 weeks follow-up

Population: 3 subjects has GAIS measurements available at both the 4 and 12 week follow ups 5 subjects had GAIS measurements only available at the 4 week follow up 2 subjects had GAIS measurements only available at the 12 week follow up

Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes

Outcome measures

Measure	Secret RF n=10 Participants Treatment with Secret RF for skin quality
Overall Aesthetic Improvement GAIS at the 4 week follow up	1.63 score on a scale Standard Deviation 0.92
Overall Aesthetic Improvement GAIS at the 12 week follow up	2 score on a scale Standard Deviation 0.71

Adverse Events

Secret RF

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Secret RF n=27 participants at risk Treatment with Secret RF for skin quality
Skin and subcutaneous tissue disorders Edema	100.0% 27/27 • 12 weeks post final treatment, up to 8 months
Skin and subcutaneous tissue disorders Erythema	100.0% 27/27 • 12 weeks post final treatment, up to 8 months
Skin and subcutaneous tissue disorders Pain	74.1% 20/27 • 12 weeks post final treatment, up to 8 months

Additional Information

Margot Doucette

Cutera

Phone: 415-656-9612

Email: mdoucette@cutera.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place