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RECRUITING
NCT07896512
NA

Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation

Sponsor: Clinique Face MD

View on ClinicalTrials.gov

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.

Official title: A Prospective, Randomized, Hemiface-Controlled Pilot Study Evaluating Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation, With Delayed Crossover

Key Details

Gender

FEMALE

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-10-30

Completion Date

2027-08-31

Last Updated

2026-10-27

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Ultraformer MPT

Micro-focused ultrasound (Classys Inc.), single session using the 1.5 mm and 2.0 mm cartridges only. Delivered to the combination hemiface at the treatment visit and to the control hemiface at Month 3.

DEVICE

SmartXide Tetra Pro fractional CO2 laser

Fractional ablative CO2 laser resurfacing (DEKA M.E.L.A. S.r.l.), single full-face session at the treatment visit with identical settings on both hemifaces.

Locations (1)

Clinique Face MD

Montreal, Quebec, Canada