Trial Outcomes & Findings for To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture (NCT NCT06404372)

The patient population for this study were all adult male and female subjects with age-related midface wrinkles who fulfilled the entry criteria (inclusion and exclusion). The study sought to enroll approximately 20% of subjects of Fitzpatrick Skin Types IV - VI. Subjects were recruited at 4 clinical sites between July 2022 and May 2024.

A total of 59 subjects were consented and screened; 2 subjects did not pass inclusion/exclusion criteria, for a total of 57 subjects enrolled. Although the protocol allowed for up to 2 run-in subjects per investigator, no run-in subjects were enrolled.

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

The primary effectiveness endpoint is the percentage 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%

Individual endpoint at 3 months for the percentage of subjects with ≥1 point change from baseline on the Lemperle Scale, as rated by a panel of three blinded evaluators. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.

Change from baseline at each timepoint of 3 and 6 months on the Lemperle Scale, as rated by a panel of three blinded evaluators. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.

Individual endpoints at each timepoint of 3, 6, 9, and 12 months for the percentage of subjects with ≥1 point change from baseline on the Lemperle Scale, as rated by the Investigator. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.

Change from baseline at each timepoint of 3, 6, 9, and 12 months on the Lemperle Scale, as rated by the Investigator. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.

Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for responders on Investigator-rated GAIS. GAIS (Global Aesthetic Improvement Scale) is a 7-point scale with values of -3 to 3 wherein the higher value indicates a greater degree of change in aesthetic appearance. Subjects must be at least Improved on both sides of the face to be considered a responder.

Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for responders on Subject-rated GAIS. GAIS (Global Aesthetic Improvement Scale) is a 7-point scale with values of -3 to 3 wherein the higher value indicates a greater degree of change in aesthetic appearance. Subjects must be at least Improved on both sides of the face to be considered a responder.

Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for change from baseline on the validated FACE-Q Age Appraisal scales as rated by the Subject. The FACE-Q Age Appraisal Scale is a patient-reported outcome measure that asks patients to select how many years older or younger they think they look compared with their actual age, ranging from -15 years to +15 years in increments of 1, with 0 being 'I look my age' at the center. The subject is instructed to circle only one number, and that number is used in analysis with no further derivation required. Treatment results at each individual timepoint are compared against baseline using a paired t-test. Presumably as subjects would prefer to appear younger than their age, negative values are considered a better result; a mean change from baseline less than zero is considered a favorable response.

Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for change from baseline on the validated FACE-Q Satisfaction with Cheeks (FACE-Q Total Score) as rated by the Subject. The FACE-Q Satisfaction with Cheeks is a patient reported outcome which consists of 5 questions pertaining to different aspects of cheek appearance. Each is evaluated on a scale of 1 to 4, with 1 being Very Dissatisfied and 4 being Very Satisfied. The raw scores for items that make up a scale are added to provide a total score. The total score is converted to a RASCH-transformed score from 0 to 100. A higher total score is indicative of greater satisfaction with the appearance of their cheeks. Treatment results at each individual timepoint are compared against baseline using a paired t-test.