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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04881149
Other study ID # CYN20-FIRM-LIPO-ROLLOVER
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2021
Est. completion date March 10, 2021

Study information

Verified date May 2022
Source Cynosure, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date March 10, 2021
Est. primary completion date March 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States JUVA Skin & Laser Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep - Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 Week (7-10 days) Post Baseline
Primary 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. 1 Week (7-10 days) Post Baseline
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