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Suture

To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture

N/A

Waitlist Available

Led By Sherly Soleiman, MD

Research Sponsored by Sutura Medical Technology LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who are able to understand the study requirements, including the obligation not to receive any other facial procedures or treatments affecting mid-face at any time during the study

Be older than 18 years old

Must not have

History of facial surgical procedures

Known bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 3, 6, 9, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of absorbable suture called Demetech Barbed PDO Suture for treating midface wrinkles. The study will involve 57 participants across multiple sites and will last

Who is the study for?

This trial is for individuals seeking treatment for midface wrinkles. Participants should be healthy adults willing to follow the study procedures and visitations over a 12-month period. Specific inclusion and exclusion criteria details are not provided, but typically these would outline health conditions or characteristics that qualify or disqualify someone from participating.

What is being tested?

The Demetech Barbed PDO Suture, an absorbable suture designed to temporarily reduce the appearance of midface wrinkles, is being tested. The study will track improvements using a wrinkle severity scale at various points, with a focus on safety and effectiveness over six months and beyond.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with sutures may include discomfort at the site of application, swelling, redness, bruising or infection. The rate of adverse events will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study's requirements and will not undergo any other facial treatments during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my face.

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I have a diagnosed bleeding disorder.

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I have active acne or noticeable acne scars in the area to be treated.

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I have had fat transferred to my midface.

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I haven't taken aspirin or herbal supplements that could increase bleeding in the last 2 weeks.

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I can't feel light touch on the middle part of my face.

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I have a history of autoimmune or connective tissue disease.

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I have had surgery that altered my facial structure.

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I cannot chew, puff my cheeks, or smile widely.

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I am currently on medication to suppress my immune system.

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I do not have serious illnesses like uncontrolled diabetes that could affect wound healing.

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I plan to have cosmetic, facial, or dental surgery soon.

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I currently have an infection or inflammation.

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I have a collagen skin disorder.

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I have only used temporary fillers like Hyaluronic Acid in my midface.

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I haven't had certain facial treatments recently or plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 3, 6, 9, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 3, 6, 9, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3, 6, 9, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement from Baseline on the Lemperle Classification Wrinkle Scale

Secondary study objectives

Change from Baseline on the Lemperle Classification Facial Wrinkle Scale as rated by a panel of three blinded evaluators

Change from Baseline on the Lemperle Classification Facial Wrinkle Scale as rated by the Investigator

Change in Investigator-rated Global Aesthetic Improvement Scale (GAIS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Demetech Barbed PDO SutureExperimental Treatment1 Intervention

Subjects who meet Inclusion/Exclusion criteria will receive treatment with Demetech Barbed PDO Sutures. Fifty-seven subjects will be treated. In addition, up to 2 run-in subjects may be treated with Demetech Barbed PDO Sutures by the investigator to allow the investigator to become familiar with Demetech Barbed PDO Suture characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Demetech Barbed PDO Suture

2022

N/A

~60

0 / 17Eligibility criteria met