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Tissue Filler

SMI-01 for Nasolabial Folds

N/A
Waitlist Available
Led By Michael Gold, MD
Research Sponsored by Sofregen Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 2 after the last treatment
Awards & highlights

Study Summary

This trial is a multicenter, unblinded, prospective feasibility study with no control group. 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.

Eligible Conditions
  • Nasolabial Folds
  • Cheek Augmentation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2 after the last treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 2 after the last treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in midface volume retention measured by Sofregen's Midface Volume Scale (MFVS) for Cheek Augmentation subjects only
Change in wrinkle severity measured by Wrinkle Severity Rating Scale (WSRS) for Nasolabial fold correction subjects only
Investigator reported duration of Common treatment site responses (CTR's) and any treatment-emergent adverse events
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nasolabial FoldExperimental Treatment1 Intervention
SMI-01 is an injectable device comprising silk particles distributed in a hydrogel carrier. The intervention will be administed once, at the Day 1 visit. An optional touch-up treatment is allowed at the Day 30 visit. The study treatment facial areas are the Right and Left nasolabial fold. The Treating Investigator will inject SMI-01 into the mid to deep dermis for correction of moderate to severe wrinkle and folds. The Treating Investigator will determine the appropriate volume of SMI-01 to be injected during initial and touch-up treatment(s).
Group II: Cheek AugmentationExperimental Treatment1 Intervention
SMI-01 is an injectable device comprising silk particles distributed in a hydrogel carrier. The intervention will be administed once, at the Day 1 visit. An optional touch-up treatment is allowed at the Day 30 visit. The midface constitutes the area of the face below the eyes and between the nose and the left or right ear. The study treatment facial areas are the Right and Left cheeks. The Treating Investigator will inject SMI-01 deeply (subcutaneous and/or supraperiosteal plane) for cheek augmentation to correct age-related volume deficiency in the midface, i.e., zygomaticomalar region, anteromedial cheek, and/or submalar region

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Who is running the clinical trial?

Sofregen Medical, Inc.Lead Sponsor
8 Previous Clinical Trials
341 Total Patients Enrolled
Symbio, LLCIndustry Sponsor
6 Previous Clinical Trials
769 Total Patients Enrolled
Michael Gold, MDPrincipal InvestigatorTennessee Clinical Research Center
14 Previous Clinical Trials
5,404 Total Patients Enrolled

Media Library

SMI-01 (Tissue Filler) Clinical Trial Eligibility Overview. Trial Name: NCT04534660 — N/A
Nasolabial Folds Research Study Groups: Nasolabial Fold, Cheek Augmentation
Nasolabial Folds Clinical Trial 2023: SMI-01 Highlights & Side Effects. Trial Name: NCT04534660 — N/A
SMI-01 (Tissue Filler) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534660 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must prospective participants meet to be eligible for this trial?

"This study is searching for 21 individuals between 22 and 65 years of age who have noticeable nasolabial folds. Additionally, there are several additional criteria that must be met which includes female participants having a negative pregnancy test within 30 days prior to enrollment as well as agreeing to use an acceptable contraception method until the conclusion of the study; both male and female patients abstaining from any facial plastic surgery or cosmetic treatments during their 24 months in the experiment; refraining from intentional weight gain/loss programs throughout this timeframe; having Wrinkle Severity Rating Scale scores no lower than 3-4 (moderate to severe) on each side of their face according"

Answered by AI

Is enrollment open for this scientific research?

"The clinicaltrials.gov registry indicates that, as of 11/23/2021, this medical trial is not recruiting participants at the moment. Nevertheless, there are currently 4 other trials actively seeking volunteers for their respective studies."

Answered by AI

Are senior citizens within the scope of this experiment?

"This trial requires participants to fall within a certain age range, which is 22-65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler
2020. "Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04534660.
~5 spots leftby Apr 2025
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