Recruiting

CO2 Laser & Ultraformer MPT

Sponsor:

Clinique Face MD

Code:

NCT07896512

Conditions

Skin Aging

Eligibility Criteria

Sex: Female

Age: 50 - 65

Healthy Volunteers: Accepted

Interventions

Ultraformer MPT

SmartXide Tetra Pro fractional CO2 laser

Study Details

Brief 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.

Conditions

Skin Aging

Study ID

NCT07896512

Start date

Oct 30, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HIFU plus fractional CO2 (combination hemiface)

Hemiface randomized to receive Ultraformer MPT micro-focused ultrasound at superficial depths (1.5 mm and 2.0 mm cartridges), followed in the same session by fractional CO2 laser resurfacing with the SmartXide Tetra Pro at the same settings as the control hemiface.

active comparator: Fractional CO2 alone (control hemiface)

Opposite hemiface receives the same fractional CO2 laser resurfacing at the treatment visit, without ultrasound. After all Month-3 assessments, this hemiface receives the same Ultraformer MPT treatment (delayed crossover).

Interventions

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.

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.

Primary outcome measure

  • Between-hemiface difference in change in FACE-Q Satisfaction with Skin score [ Time Frame: Baseline (screening visit) to Month 3 after treatment ]

Central Contacts and Locations

Central contacts

Locations

Clinique Face MD

Recruiting

Montreal, Quebec, Canada, H4C 1H1

More Information

Sponsor

Clinique Face MD

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Clinique Face MD on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.