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

Skin Laxity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881149
• Other study ID #: CYN20-FIRM-LIPO-ROLLOVER
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

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