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Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler

Nasolabial Fold Clinical Trial

Official title:
A Feasibility Study to Evaluate Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler

Clinical Trial Summary

Multicenter (two clinical sites), unblinded, no control group, prospective feasibility study. Subject participation may last up to 24 months after enrollment. Treatment will be performed at Day 1 and optionally at Day 30, with the primary safety and effectiveness evaluation at 2 months. Subjects will continue extended follow-up evaluations at 4, 6, 12, 18 and 24 months after the final injection. The duration and follow-up schedule will be identical, independent of treatment performed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04534660
Study type Interventional
Source Sofregen Medical, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date November 10, 2020
Completion date September 28, 2023
View Details
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