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.
The study will be a pivotal, blinded, multi-center study to evaluate the safety and effectiveness of Demetech Barbed PDO Suture for the treatment of mid face wrinkles. 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. Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 12 months after treatment. Subjects will be followed up for safety via telephone or email at 72 hours after receiving treatment. The primary effectiveness endpoint will be determined by the proportion of subjects with ≥1 point improvement on the Lemperle Classification of Facial Wrinkles Scale at 6 months compared to baseline as rated by a panel of three blinded evaluators. The Lemperle Scale will be used for photographic assessment by the blinded panel. Assessment of the secondary effectiveness endpoints will include the use of the Lemperle Scale by photograph by the blinded panel and live by the Investigator, as well as Investigator- and Subject-rated GAIS, and FACE-Q. Safety will be assessed at each follow-up visit. Subjects will be seen for follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months from treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
The Demetech Barbed PDO Suture will be used for the correction of midface wrinkles in all patients enrolled in this study.
Rejuva Medical Aesthetics
Los Angeles, California, United States
Cosmetic Injectables Center
Sherman Oaks, California, United States
Vedas Med Spa
The Woodlands, Texas, United States
Dr. Kristin Tarbet Facial Plastic Surgery
Bellevue, Washington, United States
Improvement From Baseline on the Lemperle Classification Wrinkle Scale
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%
Time frame: 6 Month
Percentage of Subjects With ≥1 Point Change From Baseline on the Lemperle Classification Facial Wrinkle Scale
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.
Time frame: 3, 9, and 12 Months
Change From Baseline on the Lemperle Classification Facial Wrinkle Scale as Rated by a Panel of Three Blinded Evaluators
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.
Time frame: 3 and 6 Month
Percentage of Subjects With ≥1 Point Change From Baseline on the Lemperle Classification Facial Wrinkle Scale
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.
Time frame: 3, 6, 9, and 12 Months
Change From Baseline on the Lemperle Classification Facial Wrinkle Scale as Rated by the Investigator
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.
Time frame: 3, 6, 9, and 12 Months
Responders on Investigator-rated Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: 6 Weeks, 3, 6, 9, 12 Months
Responders on Subject-rated Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: 6 Weeks, 3, 6, 9, 12 Months
FACE-Q Age Appraisal as Rated by the Subject.
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.
Time frame: 6 Weeks, 3, 6, 9, 12 Months
FACE-Q Satisfaction With Cheeks
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.
Time frame: 6 weeks, 3, 6, 9 and 12 months
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