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

NCT06404372 | Completed FDA Device

• 1 other identifier: CF-CLT-PRT
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 4

Brief Summary

The clinical trial, sponsored by Sutura Medical Technology, Inc., is a pivotal, blinded, multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture, an absorbable Polydioxanone suture, for the temporary treatment of midface wrinkles. The trial will enroll 57 subjects across up to four sites, following them over a 12-month period to evaluate improvements in wrinkles based on the Lemperle Classification Facial Wrinkle Scale. Primary endpoints include assessing the rate of adverse events and a significant reduction in wrinkle severity at 6 months, with secondary endpoints focusing on longer-term results and patient satisfaction.

Conditions

Wrinkle

Keywords

Suture; Sutura; Demetech Barbed PDO Suture; Novathreads

Outcome Measures

Primary Outcomes (1)

• Improvement from Baseline on the Lemperle Classification Wrinkle Scale

  The primary effectiveness endpoint is the proportion of subjects with ≥1 point improvement on the Lemperle Classification Facial Wrinkle Scale at 6 months compared to baseline, as rated by a panel of three blinded evaluators. The median score as rated by the blinded panel using subject photographs will be used to determine if a subject is a responder. Clinical effectiveness will be demonstrated by superiority of this 6-month response rate over a target rate of 60%

  6 Month

Secondary Outcomes (7)

• Proportion of Subjects with ≥1 Point Change from Baseline on the Lemperle Classification Facial Wrinkle Scale

  3, 9, and 12 Months

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

  3, 6, 9, and 12 Months

• Proportion of Subjects with ≥1 Point Change from Baseline on the Lemperle Classification Facial Wrinkle Scale

  3, 6, 9, and 12 Months

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

  3, 6, 9, and 12 Months

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

  6 Weeks, 3, 6, 9, 12 Months

Study Arms (1)

Demetech Barbed PDO Suture

EXPERIMENTAL

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.

Device: Demetech Barbed PDO Suture

Interventions

Demetech Barbed PDO Suture DEVICE

The Demetech Barbed PDO Suture will be used for the correction of midface wrinkles in all patients enrolled in this study.

Demetech Barbed PDO Suture

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, 22+ years of age.
• Subject received a rating, in each cheek, by PI of at least Class 1 or more for wrinkling in the midface according to the Lemperle Scale Classification of Facial Wrinkling.
• If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must have a confirmed negative urine pregnancy test result at screening. If treatment is not provided at the screening visit, a negative urine pregnancy test result is required within 7 days before treatment.
• If a woman of childbearing potential, subject confirms she will utilize at least one form of contraception throughout the duration of the study.
• Subjects who desire cheek lifting to correct age-related wrinkles in the midface as recommended by the treating investigator.
• 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.
• Subjects who are willing to participate in the study and to sign a witnessed/informed consent form.
• Subjects who are logistically able to present for all study visits and meet all study requirements.
• Subjects who are willing to complete the 30-day diary.
• Subjects who pass the pinprick and/or cotton swab facial nerve assessment.

You may not qualify if:

• Abnormal rating in midface sensation, with inability to feel a 0.4 G monofilament or a cotton wisp at any site on the midface.
• Active acne or prominent acne scars in the treatment area.
• Active inflammatory or infectious conditions.
• Allergy or foreign body sensitivities to plastic biomaterials.
• Known bleeding disorder.
• Breastfeeding, pregnant, or not on/willing to use contraception if of childbearing potential.
• Collagen skin disorder.
• Pre-existing facial asymmetry.
• History of any device use on the mid-face in the prior 6 months (e.g., laser, IPL, radiofrequency, ultrasound, micro-needling, micro needle radiofrequency, or cool based treatments).
• History of autoimmune or connective tissue disease.
• History of facelift, midface lift, lower facelift, or neck lift that changes the facial structure and anchor points.
• History of fat transfer to the midface.
• History of injectable fillers other than temporary fillers such as Hyaluronic Acid (HA) or Radiesse to the midface at any time. Permanent and semi-permanent fillers are not allowed (e.g., Poly-L-lactic acid (PLLA), Sculptra).
• History of Kybella in the prior 6 months.
• History of facial trauma in the mid-face.

Sponsors & Collaborators

• Sutura Medical Technology LLC: lead

Study Sites (4)

Rejuva Medical Aesthetics

Los Angeles, California, 90025, United States

Location

Cosmetic Injectables Center

Sherman Oaks, California, 91423, United States

Location

Vedas Med Spa

The Woodlands, Texas, 77381, United States

Location

Dr. Kristin Tarbet Facial Plastic Surgery

Bellevue, Washington, 98004, United States

Location

Study Officials

• Sherly Soleiman, MD

  Cosmetic Injectables Center

  PRINCIPAL INVESTIGATOR

• Chaitali Nangrani, MD

  Vedas Med Spa

  PRINCIPAL INVESTIGATOR

• Kristin Tarbet, MD

  Dr. Kristin Tarbet Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Amit Kocher, MD

  Rejuva Medical Aesthetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There will be a panel of the three evaluators who will be blinded. The treating physician, study staff, and office staff do not inform the panel of three blinded evaluators of whom they are viewing or of the chronological timepoint of the photograph.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: April 21, 2022
• Primary Completion: December 4, 2023
• Study Completion: August 7, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (4)