Ultraformer MPT with Fractional CO2 vs Fractional CO2 Alone for Facial Rejuvenation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this small, 6-month pilot study, each participant receives two facial treatment sides in a randomized fashion: one side is treated with the combined Ultraformer MPT and fractional CO2 laser in the same session, while the other side receives the fractional CO2 laser alone. At Month 3, the ultrasound is applied to the opposite side so that both sides end up with the combination. Ten women at a Montreal clinic are enrolled to help estimate the size and variability of the difference between sides to inform a larger trial. Standard safety and post-treatment care protocols accompany both approaches. The study uses licensed devices and standard cosmetic indications to explore potential improvements in signs of facial aging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female, aged 50 to 65 years.
2. Fitzpatrick skin phototype I to III on investigator clinical assessment.
3. Mild-to-moderate facial rhytides and lower-face/jawline laxity on investigator assessment, documented on standardized baseline photographs.
4. Stable weight (± 3 kg over the prior 6 months) with no planned major weight change.
5. Non-smoker (no current tobacco or nicotine smoking).
6. Able and willing to follow the pre-treatment skin-preparation, prophylaxis, and photoprotection regimen.
7. Able and willing to attend all study visits and phone checks and comply with pre- and post-treatment care.
8. Signed informed consent (English or French).

Exclusion Criteria:

1. Fitzpatrick phototype IV to VI.
2. Prior unilateral facial procedure, surgery, or trauma producing visible left-right asymmetry of the treatment zones.
3. Thin or angular facial morphology, prior facial fat grafting, buccal fat pad excision, or visible midface/temporal hollowing at baseline.
4. Prior HIFU, radiofrequency microneedling, Ultherapy, or ablative laser to the face within 12 months; facial filler in treatment zones within 6 months; neuromodulator within 3 months.
5. Active facial dermatosis or infection; keloid or hypertrophic scarring history; immunosuppression; isotretinoin within 6 months.
6. Pregnancy, planned pregnancy, or breastfeeding.
7. Planned or anticipated weight change greater than 5 kg, bariatric surgery, or major dental/orthognathic work during the study.
8. Any condition that, in the investigator's judgment, makes participation unsafe or data uninterpretable.

Where it's running

• Clinique Face MD
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Sami P. Moubayed, MD, FRCSC — Clinique Face MD
• Study coordinator: Sami P. Moubayed, MD, FRCSC
• Email: recherche@cliniquefacemd.com
• Phone: 514-447-9435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.