An interventional study of SUPERB in Lax Skin, sponsored by Sofwave Medical LTD. Active, not recruiting at 1 site in Canada. Open to female participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Sofwave Medical LTD · Not applicable, Interventional, and Treatment
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.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →Sofwave Medical LTD is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(at least 10 subjects) will undergo 2 SofWave treatments (4 weeks apart) on the face and submental areas. In addition, small superficial punch biopsies in the submental area will be taken from 3 subjects of the treatment group.
Device: SUPERB
The control subjects (at least 10 subjects) will have 3 in-person visits. 3 of these subjects will also have biopsies taken during their first visit and at second follow-up (FU2) at week 24.
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.
This study also gives Tirzepatide. No intervention listed here names it: that was found by reading the record.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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