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

NCT04534660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-05-31

No results posted yet for this study

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.

Conditions

  • Nasolabial Fold
  • Cheek Augmentation

Interventions

DEVICE

SMI-01

SMI-01 is a device consisting of silk particles in a hydrogel carrier.

Sponsors & Collaborators

  • Symbio, LLC

    collaborator INDUSTRY

  • Sofregen Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Leslie S. Baumann, MD · Baumann Cosmetic & Research Institute

  • Stacy Smith, MD · California Dermatology & Clinical Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2021-08-24
Completion
2023-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534660 on ClinicalTrials.gov