Are you a woman aged 30 to 50 considering weight management using glucagon-like peptide-1 agonist (GLP-1) injections?
You may qualify to participate in a clinical trial exploring how medication-assisted weight loss can impact skin. The study will assess whether Sofwave® (the study device), a non-invasive skin tightening treatment, can help prevent the appearance of facial hollowing (commonly known as “Ozempic® Face”) associated with weight loss.
There will be 4 office visits at the study site at Dr. Carruthers office in the Fairview neighborhood of Vancouver. Some participants may be asked to attend an additional visit for a skin biopsy. Costs relating to attending visits such as parking are reimbursed $150 per ICF.
In addition, there will be several medical visits for the GLP-1 medication. Most of these can be done virtually.
You are expected to:
Sofwave® is a non-invasive medical device that uses ultrasound technology to deliver heat to specific layers of the skin. The purpose of this treatment is to stimulate the body’s natural production of collagen, which may help improve skin firmness and reduce the appearance of wrinkles. Unlike surgical procedures, Sofwave® does not require incisions or injections. It takes about 45 minutes for the full face treatment.
In this study, Sofwave® is being used under controlled conditions to better understand its safety, effectiveness, and participant experience. It is Health Canada–approved, considered safe, and generally well-tolerated. There is no downtime required after Sofwave® treatment, and participants can return to everyday activities immediately, however it has not been specifically used to address lax tissue due to weight loss for Tirzepatide and therefore its use in this study is experimental.
Most people describe the treatment as producing a sensation of warmth or tingling on the skin. Some participants may feel brief discomfort during the pulses of energy, but this is usually well-tolerated. Participants will be offered topical numbing cream before the procedure, and additional measures are in place to keep you comfortable. If you experience pain beyond mild or temporary discomfort, let the study team know immediately so adjustments can be made.
Participants will be prescribed a GLP-1 receptor agonist medication (most likely tirzepatide, but this will be confirmed before the study begins).
The doctors at the Obesity Medicine and Diabetes Institute will prescribe and oversee your GLP-1 treatment. They are internal medicine physicians with specialized training in obesity management. They will order any required blood tests, prescribe the medication at gradually increasing doses, and monitor your progress to ensure the medication is being taken safely.
Common side effects can include nausea, vomiting, diarrhea, or constipation. These are usually mild and tend to improve over time. If you experience side effects that are severe or persistent, the study doctors will help adjust your treatment as needed.
These medical visits are no cost and covered under MSP. However, a referral from another physician (such as your family doctor or a walk-in clinic) is required before your first consultation.
Yes. We need to complete all baseline assessments and photographs of participants before they begin GLP-1 medication. You will be instructed to have your first injection soon after your initial visit to the study site (Dr. Carruthers’ office). If you have already started taking a GLP-1 medication, you are not eligible to participate in this study.
You will need to apply for reimbursement through your third-party drug insurance. Some private drug plans offered by employers may cover GLP-1 medication if you meet their eligibility criteria.
Please note: coverage varies by insurance provider, and participants may be responsible for any costs not covered by insurance.
No. Biopsies are not required for participation in the study. They are optional for those who are interested.
A skin biopsy is a very small sample of skin, about 3 millimeters in diameter, that is examined under a microscope by a pathologist. These samples help researchers study changes in collagen, elastin, and other skin structures.
Biopsies in this study are taken from underneath the chin, where any small scars will not be visible from the front. Participants who opt in will provide two biopsies at the first visit (Month 0) and two more at the 6-month visit.
The procedure is quick (about 5 minutes):
Risks such as minor pain, bleeding, or infection are rare. Participants can return to normal activities immediately. Stitches should dissolve on their own but may be removed after 7 days if needed. A virtual follow-up with photos is done 2 weeks later to confirm proper healing.
Participants who provide biopsies will be compensated $1,000 at the end of the study, once all four biopsies have been received.
You may notice improvements in your skin appearance from Sofwave® treatment. However, benefits cannot be guaranteed. The study may provide valuable information to help improve care for future patients.
All subjects will receive two Sofwave treatments. You will be randomised to receive your first Sofwave treatment either at Month 0 or at Month 6.
Yes. Your records will be kept confidential as required by law. Any published results will not identify you personally.
Yes. Participation is voluntary. You may withdraw at any time without penalty or impact on your medical care.
You will be given the contact information of the study coordinator and physician. You may also contact the Research Ethics Board overseeing this study if you have questions about your rights as a participant.
If you have additional questions, please fill out the contact form and the study coordinator will be in touch to answer your questions.
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