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Recruiting
NCT07896512
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Conditions: Skin Aging
Sex: Female
Ages: 50 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 10
Sponsor: Clinique Face MD
Location: Clinique Face MD Montreal Quebec
Summary
This pilot study compares fractional CO2 laser resurfacing alone with the same laser combined, in the same session, with micro-focused ultrasound (Ultraformer MPT) for signs of facial skin aging in women aged 50 to 65. Both devices are licensed by Health Canada and are used within their licensed indications.
Each participant's two facial sides are compared: one side, chosen at random, receives the combination and the other side receives the laser alone. The second side receives the ultrasound at Month 3, so both sides end with the combination. Ten participants are enrolled at one clinic in Montreal and followed for 6 months. As a pilot, the study estimates the size and variability of the difference between sides to inform a larger trial.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07896512). StuddyBuddy aggregates publicly available trial information.