Trial Outcomes & Findings for Multi-Center Pivotal Study of Radiofrequency Device (NCT NCT04569253)

NCT ID: NCT04569253

Last Updated: 2022-06-14

Results Overview

Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: 12 Week Follow Up
• Results posted on: 2022-06-14

Participant Flow

Unit of analysis: flanks

Participant milestones

Measure	All Study Participants Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.
Overall Study STARTED	65 130
Overall Study Control Flanks	65 65
Overall Study Treatment Flanks	65 65
Overall Study COMPLETED	57 114
Overall Study NOT COMPLETED	8 16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Center Pivotal Study of Radiofrequency Device

Baseline characteristics by cohort

Measure	RF Device Arm n=65 Participants Single arm, self controlled. TempSure: Non-invasive radiofrequency treatments
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	7 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	54 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	1 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type I	1 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type II	18 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type III	34 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type IV	9 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type V	1 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type VI	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Week Follow Up

Population: 1 subject attended the 12 week follow up so was considered complete, but did not have pictures taken for this outcome measure.

Correct identification of pre-treatment images vs. the 12-week follow up images by blinded evaluators.

Outcome measures

Measure	All Subject Participants n=112 photographs Subjects will receive treatments with the RF device on one flank. The other flank will be left untreated to serve a control.
% of Photos Identified Correctly When Comparing 12 Week Follow Up to Baseline	57 % of photos identified correctly

Adverse Events

RF Device

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	RF Device n=65 participants at risk Subjects received treatment on this flank with the RF device.	Control n=65 participants at risk Subjects received treatments on one flank, and their other flank (which was untreated) was used as the control. No intervention or treatment occurred on this flank.
Skin and subcutaneous tissue disorders erythema	15.4% 10/65 • Adverse events were collected throughout subject participation in the study, approximately 6 months. Only subjects who received treatment on the treatment area observed adverse events (not on the control flank). Since no treatment was conducted on the control flanks, no adverse events can or should be expected for them.	0.00% 0/65 • Adverse events were collected throughout subject participation in the study, approximately 6 months. Only subjects who received treatment on the treatment area observed adverse events (not on the control flank). Since no treatment was conducted on the control flanks, no adverse events can or should be expected for them.
Skin and subcutaneous tissue disorders edema	1.5% 1/65 • Adverse events were collected throughout subject participation in the study, approximately 6 months. Only subjects who received treatment on the treatment area observed adverse events (not on the control flank). Since no treatment was conducted on the control flanks, no adverse events can or should be expected for them.	0.00% 0/65 • Adverse events were collected throughout subject participation in the study, approximately 6 months. Only subjects who received treatment on the treatment area observed adverse events (not on the control flank). Since no treatment was conducted on the control flanks, no adverse events can or should be expected for them.
Skin and subcutaneous tissue disorders pain	4.6% 3/65 • Adverse events were collected throughout subject participation in the study, approximately 6 months. Only subjects who received treatment on the treatment area observed adverse events (not on the control flank). Since no treatment was conducted on the control flanks, no adverse events can or should be expected for them.	0.00% 0/65 • Adverse events were collected throughout subject participation in the study, approximately 6 months. Only subjects who received treatment on the treatment area observed adverse events (not on the control flank). Since no treatment was conducted on the control flanks, no adverse events can or should be expected for them.

Additional Information

Jamie Trimper

Cynosure

Phone: (978) 256-4200

Email: jamie.trimper@cynosure.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
• Publication restrictions are in place

Restriction type: OTHER