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

Cynosure, Inc.7 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Laxity

Interventions

TempSure treatmentDEVICE

Self-controlled, single-arm study using the TempSure device.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

JUVA Skin & Laser Center

New York, New York, United States

Outcomes

Primary Outcomes

Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient

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.

Time frame: 1 Week (7-10 days) Post Baseline

Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient

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.

Time frame: 1 Week (7-10 days) Post Baseline

Data from ClinicalTrials.gov

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