Open-label, randomized double-arm prospective, single-center, self-controlled clinical study.
Eligible subjects are patients who are interested in starting treatment with Tirzepatide injections. Subjects will be divided into two groups. The test group will include at least 10 subjects who will be treated to characterize changes in facial and neck skin laxity as well as facial wrinkles in relation to SofWave treatment, in a population of subjects beginning Tirzepatide for weight loss. The control group will also include at least 10 subjects, who will not be treated. In addition, small superficial punch biopsies in the submental area will be taken from 3 subjects in each group. All Subjects will receive their first Tirzepatide injection within 48 hours after baseline assessment (± biopsy). Treatment Group: Subjects will receive two SofWave treatments, 4 weeks apart, applied to the full face and neck. Three subjects will undergo biopsies at baseline (2 weeks before first treatment) and at Week 26 (20 weeks after the second treatment). Biopsy subjects will attend additional visits, including telehealth follow-ups to monitor healing. Non-biopsy subjects will attend 3 in-person visits (Baseline, Week 4, Week 24). Final follow-up occurs approximately 24-26 weeks after the first treatment. Control Group: Subjects will not receive SofWave during the study period. Non-biopsy subjects will attend 3 in-person visits (Baseline, Week 4, Week 24). Three subjects will undergo biopsies at Week 0 and Week 24, with additional telehealth follow-ups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.
Dr.Jean Carruthers Cosmetic Surgery
Vancouver, Canada
Improvement in the appearance of lax skin
The efficacy endpoint criteria for success is defined as the rate of 'improved' or 'no change' at the Treatment group compared to Control group at 20 weeks post last SofWave treatment for Treatment group and following FU1 for Control group (FU2).
Time frame: 20 WEEKS POST LAST TREATMENT
Histology
The histological effects will be determined via H\&E (Haematoxylin and Eosin) staining and special staining such as Alcian Blue, Masson trichrome and/or Verhoeff Van Gieson staining.
Time frame: 20 weeks post last treatment
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