Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks

Not Applicable

Completed

• Conditions: Skin Laxity
• Interventions: Device: TempSure treatment

• Registration Number: NCT04881149
• Lead Sponsor: Cynosure, Inc.

Brief Summary

The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.

Detailed Description

Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a control.

Study Timeline

• Study Start: 2021-02-12
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-11
• Results First Submitted: 2022-02-11
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Results First Posted: 2022-06-01
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Subject has completed their participation in the CYN20-FIRM-LIPO study.

Exclusion Criteria

• The subject has not had any other treatment in the treatment area after their involvement in the CYN20-FIRM-LIPO study.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Study Participants	TempSure treatment	The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment).

Primary Outcome Measures

Name	Time	Method
Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient	1 Week (7-10 days) Post Baseline	Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of elastin. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of elastin (control compared to treatment) is reported.
Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient	1 Week (7-10 days) Post Baseline	Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of collagen. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of collagen (control compared to treatment) is reported.

Trial Locations

Locations (1)

JUVA Skin & Laser Center; 🇺🇸 New York, New York, United States