Skin AgingULTRA-CO2NCT07896512
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
A study testing Ultraformer MPT and SmartXide Tetra Pro fractional CO2 laser in people with Skin Aging, run by Clinique Face MD at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Ultraformer MPT and SmartXide Tetra Pro fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, aged 50 to 65 years.
- Fitzpatrick skin phototype I to III on investigator clinical assessment.
- Mild-to-moderate facial rhytides and lower-face/jawline laxity on investigator assessment, documented on standardized baseline photographs.
- Stable weight (± 3 kg over the prior 6 months) with no planned major weight change.
- Non-smoker (no current tobacco or nicotine smoking).
- Able and willing to follow the pre-treatment skin-preparation, prophylaxis, and photoprotection regimen.
- Able and willing to attend all study visits and phone checks and comply with pre- and post-treatment care.
- Signed informed consent (English or French).
Who cannot join
- Fitzpatrick phototype IV to VI.
- Prior unilateral facial procedure, surgery, or trauma producing visible left-right asymmetry of the treatment zones.
- Thin or angular facial morphology, prior facial fat grafting, buccal fat pad excision, or visible midface/temporal hollowing at baseline.
- 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.
- Active facial dermatosis or infection; keloid or hypertrophic scarring history; immunosuppression; isotretinoin within 6 months.
- Pregnancy, planned pregnancy, or breastfeeding.
- Planned or anticipated weight change greater than 5 kg, bariatric surgery, or major dental/orthognathic work during the study.
- Any condition that, in the investigator's judgment, makes participation unsafe or data uninterpretable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Clinique Face MD
Montreal, Quebec, H4C 1H1
About this study
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
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
- Being tested
- Ultraformer MPT, SmartXide Tetra Pro fractional CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraformer MPTDevice
Also called Micro-focused ultrasound (HIFU)
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 laserDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| HIFU plus fractional CO2 (combination hemiface) | Experimental | 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. Receives: Device: Ultraformer MPT; Device: SmartXide Tetra Pro fractional CO2 laser |
| Fractional CO2 alone (control hemiface) | Active comparator | 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). Receives: Device: Ultraformer MPT; Device: SmartXide Tetra Pro fractional CO2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-hemiface difference in change in FACE-Q Satisfaction with Skin score
FACE-Q Satisfaction with Skin (12 items, Rasch-transformed 0 to 100, higher is better), completed by the participant for each hemiface. Change from baseline per hemiface; difference between hemifaces (combination minus control).
Measured: Baseline (screening visit) to Month 3 after treatment
Secondary outcomes (2)
Between-hemiface difference in blinded-rater Global Aesthetic Improvement Scale (GAIS)
Change from baseline photographs rated from +3 (very much improved) to -3 (very much worse), higher is better; median of three blinded raters per hemiface; difference between hemifaces.
Measured: Month 3 after treatment
Between-hemiface difference in patient-rated Global Impression of Change (PGIC)
Participant rating of change per hemiface from +3 (very much better) to -3 (very much worse), higher is better; difference between hemifaces.
Measured: Month 3 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within-participant comparison: each participant's left and right hemifaces are randomized 1:1 to the two arms. The control hemiface receives the ultrasound at Month 3 (delayed crossover).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Face MD
- Sponsor type
- University, hospital or other
- Collaborators
- Cartessa Aesthetics
- Responsible party
- Sponsor
- Investigators
- Sami P. Moubayed, MD, FRCSC, Principal investigator, Clinique Face MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896512
- Sponsor's protocol ID
- FMD-ULT-CO2-2026-001
- Other IDs
- 2026-09-003
- Acronym
- ULTRA-CO2
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant-level data will not be made publicly available or shared externally. Given the small sample and the central role of facial images, de-identification cannot reliably prevent re-identification; findings are disseminated as aggregate results.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07896512
- Acronym / sponsor ID
- ULTRA-CO2 / FMD-ULT-CO2-2026-001
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Clinique Face MDUniversity, hospital or other
- Collaborators
- Cartessa Aesthetics
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Within-participant comparison: each participant's left and right hemifaces are randomized 1:1 to the two arms. The control hemiface receives the ultrasound at Month 3 (delayed crossover).
| Arm | Type | Receives |
|---|---|---|
| HIFU plus fractional CO2 (combination hemiface) | Experimental | Device: Ultraformer MPT, Device: SmartXide Tetra Pro fractional CO2 laserHemiface 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. |
| Fractional CO2 alone (control hemiface) | Active comparator | Device: Ultraformer MPT, Device: SmartXide Tetra Pro fractional CO2 laserOpposite 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). |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female, aged 50 to 65 years.
- Fitzpatrick skin phototype I to III on investigator clinical assessment.
- Mild-to-moderate facial rhytides and lower-face/jawline laxity on investigator assessment, documented on standardized baseline photographs.
- Stable weight (± 3 kg over the prior 6 months) with no planned major weight change.
- Non-smoker (no current tobacco or nicotine smoking).
Key exclusion criteria (8 listed)
- Fitzpatrick phototype IV to VI.
- Prior unilateral facial procedure, surgery, or trauma producing visible left-right asymmetry of the treatment zones.
- Thin or angular facial morphology, prior facial fat grafting, buccal fat pad excision, or visible midface/temporal hollowing at baseline.
- 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.
- Active facial dermatosis or infection; keloid or hypertrophic scarring history; immunosuppression; isotretinoin within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultraformer MPTAlso: Micro-focused ultrasound (HIFU)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 | Fractional CO2 alone (control hemiface), HIFU plus fractional CO2 (combination hemiface) |
| SmartXide Tetra Pro fractional CO2 laserAlso: Fractional CO2 laserFractional 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. | Device | Fractional CO2 alone (control hemiface), HIFU plus fractional CO2 (combination hemiface) |
Primary outcome
Between-hemiface difference in change in FACE-Q Satisfaction with Skin score
Time frame: Baseline (screening visit) to Month 3 after treatment
FACE-Q Satisfaction with Skin (12 items, Rasch-transformed 0 to 100, higher is better), completed by the participant for each hemiface. Change from baseline per hemiface; difference between hemifaces (combination minus control).
2 secondary outcomes
Between-hemiface difference in blinded-rater Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 3 after treatment
Between-hemiface difference in patient-rated Global Impression of Change (PGIC)
Time frame: Month 3 after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Participant-level data will not be made publicly available or shared externally. Given the small sample and the central role of facial images, de-identification cannot reliably prevent re-identification; findings are disseminated as aggregate results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sami P. Moubayed, MD, FRCSC principal investigator
Clinique Face MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraformer MPT and SmartXide Tetra Pro fractional CO2 laser in people with Skin Aging, run by Clinique Face MD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sami P. Moubayed, MD, FRCSC (514-447-9435, recherche@cliniquefacemd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.