NCT04085822

Histology of SMA-001 in the Abdomen

A Histologic Study of Silk Medical Aesthetics Device in the Abdomen of Patients Undergoing Abdominoplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Silk Medical Aesthetics, Inc. · Industry
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Silk Medical Aesthetics' Inc. device, SMA-001, is currently under development as a dermal filler to fill wrinkles and folds. This study is designed to collect short-term visual, photographic, and histological and safety data on small aliquots of the product as part of device development. It is an open label study involving up to three investigational sites and a maximum enrollment of 10 subjects. Juvéderm Ultra Plus XC, an FDA-approved dermal filler will serve as a control device. Briefly, the investigational product and the control device will be injected into the abdomen of patients intending to undergo abdominoplasty at a later date. The patients will be followed for 30 days post injection through visual observation. At 30 days post injection, the injected gel and associated tissue will be removed via biopsy during the abdominoplasty surgery and histology slides created for analysis.

Conditions

• Abdominoplasty
• Medical Aesthetics

Interventions

Type	Name	Description
DEVICE	SMA-001	Intra-dermal injection of SMA-001 and control device.

Timeline

• Start date: 2019-08-29
• Primary completion: 2019-12-23
• Completion: 2020-01-17
• First posted: 2019-09-11
• Last updated: 2020-03-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study