NCT04085822

Histology of SMA-001 in the Abdomen

Completed NA Last updated 19 March 2020

What this trial tests

NA trial testing SMA-001 in Abdominoplasty in 13 participants. Completed in 17 January 2020.

Timeline

29 August 2019

Primary endpoint
23 December 2019

17 January 2020

Quick facts

Lead sponsor	Silk Medical Aesthetics, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	13
Start date	29 August 2019
Primary completion	23 December 2019
Estimated completion	17 January 2020
Sites	3 locations across United States

Drugs / interventions tested

• SMA-001

Conditions studied

• Abdominoplasty — all drugs for Abdominoplasty →
• Medical Aesthetics — all drugs for Medical Aesthetics →

Sponsor

Silk Medical Aesthetics, Inc.

Who can join

Adults 25 to 65, female only, with Abdominoplasty or Medical Aesthetics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Silk Bioconjugates: From Chemistry and Concept to Application.
   Matthew SAL, Seib FP. · · 2024 · cited 17× · PMID 36706352 · DOI 10.1021/acsbiomaterials.2c01116
2. Impact of silk hydrogel secondary structure on hydrogel formation, silk leaching and in vitro response.
   Egan G, Phuagkhaopong S, Matthew SAL, Connolly P, et al · · 2022 · cited 17× · PMID 35260610 · DOI 10.1038/s41598-022-07437-4