AzTrials
AzTrials

Skin Physiology After Fractional CO₂ Laser TreatmentNCT07895303

Pre- and Post-procedure Skin Knowledge Study

A study testing CO₂ fractional laser skin treatment, Thermage skin tightening treatment and Neutral broad-spectrum sunscreen in people with Skin Physiology After Fractional CO₂ Laser Treatment and Skin Physiology After Thermage Treatment, run by ChinaNorm at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this exploratory clinical trial is to characterize and compare skin clinical signs, skin physiology and subjective well-being before and after CO₂ fractional laser or Thermage treatment. Read more about this study

Who is it for?
Ages 30 to 59 years, women onlyHealthy volunteers can take part
What is being tested?
CO₂ fractional laser skin treatment, Thermage skin tightening treatment and Neutral broad-spectrum sunscreen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
9 Oct 2026to 11 Jun 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 30 to 59 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1) Asian women, with age range from 30 to 59 years old;
  • 2) Be in general good health and good mental state;
  • 3) Presenting healthy skin as determined by Dermatologist;
  • 4) All Fitzpatrick skin types;
  • 5) All skin types on face (dry, normal, oily and combination) by subjects' self-perceived, with sensitive skin status confirmed and documented by a dermatologist;
  • 6) Facial skin exhibits specific characteristics (the mean baseline needs to be the same for 2 groups for all those parameters, before the pre-treatment phase T-2w) which require dermatological evaluation, detailed as follows: Crow's feet wrinkles: grade: 3≤ grade ≤5 (SKIN AGING ATLAS, page 40 to 41) Underneath eyes wrinkles: 3≤ grade ≤6 (SKIN AGING ATLAS, page 46 to 47) Ptosis of the lower part of the face: 1≤ grade ≤3 (SKIN AGING ATLAS, page 66 to 67) Lack of firmness: 3≤ grade ≤6 (9-point scale, 0 is the worst, 9 is the best) Pigmentary spots: 3≤ grade ≤5 (SKIN AGING ATLAS, page 79 to 81) (only for CO2 fractional laser Group)
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  • 7) Willing to participate in one session of aesthetic procedure, either Fractional Ultrapulse CO₂-laser or Thermage procedure, after a 2-week wash-out period, followed by a 10-day self-recovery observation period.
  • 8) Aware and willing to accept that after a 10-day healing period, if the skin is not "ready" for the application of cosmetic products as determined by a dermatologist, they will be required to withdraw from the study;
  • 9) Have clean testing area (face): free of make-up on face, free of skin care products (lotions, sunscreens), make-up, perfumes, or other topical products on the visit day;
  • 10) Not currently be participating and will not participate in any other study involving the test area (face) for the duration of the study;
  • 11) Not have participated in any other study involving the test area (face) in the past 1 month;
  • 12) Be willing to read, understand and able to sign the Informed Consent Form \& Photo Release Form;
  • 13) Be willing to comply with all study protocol requirements.

Who cannot join

  • 1) Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
  • 2) Have any skin problems to impact clinical assessment, such as large areas of acne, scars, and open wounds, etc.;
  • 3) Having used antihistamine drugs in the past 1 week and one month after the treatment or immunosuppressants in the past 1 month;
  • 4) Take anti-allergic drug/injections in the past 1 month;
  • 5) Presently have allergies, allergic dermatitis or skin disease;
  • 6) Have sensitivity or even allergy to topical products, ingredients or fragranced products;
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  • 7) Having a history of allergies, including but not limited to allergies to certain ingredients in cosmetics.
  • 8) Have history of suffering from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
  • 9) Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
  • 10) Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);
  • 11) Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 6 month; For Thermage group: priority screening for fillers, thread lifts, and metallic implants in the treatment area; For CO2 fractional laser Group: priority screening for laser treatments, peeling procedures, isotretinoin treatmentrecently and risk of herpes simplex virus (HSV) reactivation and post-inflammatory hyperpigmentation (PIH);
  • 12) Have excessive sun exposure or ultraviolet light in the past 1 month;
  • 13) Have applied Alpha hydroxyl acid, ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives (such as Diane 35®,Jasmine®,Holgyeme®,Syndi 35®,Regulon®);
  • 14) Avoid providing emergency contact;
  • 15) Subjects that are not compliant to the selection criteria or not proper for participation as determined by Principal Investigator;
  • 16) An employee of the cosmetic companies or Shanghai China-Norm Quality Technical Service Co., Ltd.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,

    Shanghai, Shanghai Municipality

    Yanwen Jiang, 13501700841, jiangyanwen@china-norm.com

    Recruiting

Other trials in China

About this study

The goal of this exploratory clinical trial is to characterize and compare skin clinical signs, skin physiology and subjective well-being before and after CO₂ fractional laser or Thermage treatment. It will also explore correlations between skin parameters and investigate the optimal timing for starting skincare products after the procedure. The main questions it aims to answer are:

  • How do skin clinical signs, physiological indicators and subjective well-being change pre- and post-procedure for CO₂ fractional laser and Thermage?
  • Are there correlations between different skin parameters before and after the aesthetic procedure?
  • When is the optimal time to begin using skincare products after treatment?
Read more

Researchers will compare CO₂ fractional laser versus Thermage. Clinical assessors remain blinded to treatment group assignment; participants are unblinded due to visible procedural effects.

Participants will:

  • Use only neutral skincare products (cream + sunscreen) during a 2-week wash-out period
  • Receive one session of either CO₂ fractional laser or Thermage treatment
  • Complete a 10-day self-recovery period, then attend follow-up assessments for up to 12 weeks
  • Maintain neutral skincare products (cream + sunscreen) for the full 12-week post-treatment phase
  • Attend clinic visits for skin clinical and physiological evaluations
Being tested
CO₂ fractional laser skin treatment, Thermage skin tightening treatment, Neutral broad-spectrum sunscreen, Neutral moisturizing cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CO₂ fractional laser skin treatmentDevice

    Single session of superficial CO₂ fractional laser for skin aesthetic improvement. All subjects maintain neutral skincare products throughout wash-out and follow-up periods.

  • Thermage skin tightening treatmentDevice

    Single session of superficial Thermage for skin aesthetic improvement. All subjects maintain neutral skincare products throughout wash-out and follow-up periods.

  • Neutral broad-spectrum sunscreenOther

    Standardized neutral broad-spectrum sunscreen for all subjects. Used throughout the 2-week wash-out phase, 10-day recovery period and 12-week follow-up period. Not an investigational product.

  • Neutral moisturizing creamOther

    Standardized neutral moisturizing cream for all subjects. Used throughout the 2-week wash-out phase, 10-day recovery period and 12-week follow-up period. Not an investigational product.

Study groups in NCT07895303
Study groupRoleWhat they receive
CO₂ Fractional Laser Treatment GroupExperimentalSubjects receive one session of CO₂ fractional laser after a 2-week wash-out phase, followed by a 10-day recovery period and 12-week follow-up using neutral skincare products (cream + sunscreen).
Receives: Device: CO₂ fractional laser skin treatment; Other: Neutral broad-spectrum sunscreen; Other: Neutral moisturizing cream
Thermage Treatment GroupExperimentalSubjects receive one session of Thermage after a 2-week wash-out phase, followed by a 10-day recovery period and 12-week follow-up using neutral skincare products (cream + sunscreen).
Receives: Device: Thermage skin tightening treatment; Other: Neutral broad-spectrum sunscreen; Other: Neutral moisturizing cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Grading by Dermatologist for efficacy

    A validated dermatologist conducts clinical scoring of facial indicators. Crow's feet wrinkles, under-eye wrinkles, lower facial ptosis and pigment spot density are scored according to the Atlas of Skin Aging Scale. The Atlas of Skin Aging Scale has item-specific score ranges: Crow's feet wrinkles / lower facial ptosis (0 to 6), pigment spot density (0 to 7), under-eye wrinkles (0 to 9); higher scores indicate greater severity of skin aging findings (worse outcome).

    Assessments are performed in a standard environment with uniform 6500K cool daylight. The same validated dermatologist assesses all subjects starting from T-2w. Any unexpected change of grader or grading environment will be documented as protocol deviation.

    Measured: T-2w (2 weeks before procedure), T0 (baseline, before procedure), Timm (right after procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

Secondary outcomes (9)
  1. Facial Photos Tracking by ColorFace

    Subjects wear hair band, close eyes and cooperate for image-position matching. The same trained technician captures facial images using ColorFace (Newtone, France). Front, left and right facial photos are acquired under standard (STD60), cross polarized (CP), parallel polarized (PP) and UV modalities. Skin tone (L* Lightness, a* Redness, b* Yellowness) and skin gloss (GC value) are analyzed via IPP software; skin evenness (Even/h76') is analyzed by China-norm self-developed software.

    Measured: T0 (baseline, before procedure), Timm (right after procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  2. LC-OCT in vivo imaging measurement

    A trained technician performs in vivo LC-OCT imaging measurement with portable probe on one cheek side. Left/right cheek is assigned per subject by randomization table at 1 day before procedure and remains consistent across all visits. Five repeated measurements are performed on the test area at each time point.

    Measured: 1d (1 day before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  3. Facial Photos Tracking by E-mirror

    Subjects wear hair band, close eyes and cooperate for image-position matching. The same trained technician captures facial photos using E-mirror device starting from baseline.

    Measured: T-1d (1 day before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  4. Skin Firmness (R0, Uf) measured by Cutometer® Dual MPA 580

    Based on suction and stretch principle, Cutometer® Dual MPA 580 (Courage \& Khazaka, Germany) applies negative pressure to draw skin into test probe. Non-contact optical system detects skin penetration depth, analyzed via MPA software to calculate skin elastic properties. The same validated technician performs measurements on cheek. Left/right cheek is assigned for each subject by randomization table at T0 and kept consistent across all visits with fixed Cutometer parameters. Two measurements are performed on assigned cheek at each time point. Averaged R0 (Uf, skin firmness) is used for statistical analysis, all curves will be preserved.

    Measured: T0 (baseline, before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  5. TEWL Measurement by Tewameter® TM 300

    Tewameter® TM300 (Courage + Khazaka, Germany) adopts open-chamber design. The probe indirectly detects density gradient of skin water evaporation by two pairs of temperature and relative humidity sensors to assess TEWL continuously without disturbing skin microenvironment, results expressed in g/h/m². The same validated technician performs measurements on cheek . Left/right cheek is assigned for each subject by randomization table at T0 and kept consistent across all visits. Two measurements are performed on assigned cheek at each time point.

    Measured: T0 (baseline, before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  6. Skin Hydration Measurement by Corneometer CM825

    Corneometer CM825 (Courage \& Khazaka, Germany) measures skin moisture content by capacitance method. The capacitance value is proportional to stratum corneum water content under controlled physical and physiological confounders. Measurements are performed on cheek . Left/right cheek is assigned for each subject by randomization table at T0 and kept consistent across all visits. Three measurements (variation<10%) are performed on test area at each time point.

    Measured: T0 (baseline, before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  7. Skin Gross Elasticity (R2, Ua/Uf) measured by Cutometer® Dual MPA 580

    Based on suction and stretch principle, Cutometer® Dual MPA 580 (Courage \& Khazaka, Germany) applies negative pressure to draw skin into test probe. Non-contact optical system detects skin penetration depth, analyzed via MPA software to calculate skin elastic properties. The same validated technician performs measurements on cheek. Left/right cheek is assigned for each subject by randomization table at T0 and kept consistent across all visits with fixed Cutometer parameters. Two measurements are performed on assigned cheek at each time point. Averaged R2 (Ua/Uf, gross elasticity) is used for statistical analysis, all curves will be preserved.

    Measured: T0 (baseline, before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  8. Skin Net Elasticity (R5, Ur/Ue) measured by Cutometer® Dual MPA 580

    Based on suction and stretch principle, Cutometer® Dual MPA 580 (Courage \& Khazaka, Germany) applies negative pressure to draw skin into test probe. Non-contact optical system detects skin penetration depth, analyzed via MPA software to calculate skin elastic properties. The same validated technician performs measurements on cheek. Left/right cheek is assigned for each subject by randomization table at T0 and kept consistent across all visits with fixed Cutometer parameters. Two measurements are performed on assigned cheek at each time point. Averaged R5 (Ur/Ue, net elasticity) is used for statistical analysis, all curves will be preserved.

    Measured: T0 (baseline, before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

  9. Skin Biological Elasticity (R7, Ur/Uf) measured by Cutometer® Dual MPA 580

    Based on suction and stretch principle, Cutometer® Dual MPA 580 (Courage \& Khazaka, Germany) applies negative pressure to draw skin into test probe. Non-contact optical system detects skin penetration depth, analyzed via MPA software to calculate skin elastic properties. The same validated technician performs measurements on cheek. Left/right cheek is assigned for each subject by randomization table at T0 and kept consistent across all visits with fixed Cutometer parameters. Two measurements are performed on assigned cheek at each time point. Averaged R7 (Ur/Uf, biological elasticity) is used for statistical analysis, all curves will be preserved.

    Measured: T0 (baseline, before procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start9 Oct 2026
  3. Primary completion11 Jun 2027 (estimated)
  4. Study completion11 Jun 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895303
Sponsor's protocol ID
A26104006 & A26104007
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CO₂ fractional laser skin treatment, Thermage skin tightening treatment and Neutral broad-spectrum sunscreen in people with Skin Physiology After Fractional CO₂ Laser Treatment and Skin Physiology After Thermage Treatment, run by ChinaNorm at 1 site in China.

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 13 inclusion and 16 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 26 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 China. 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 Yanwen Jiang (13501700841, jiangyanwen@china-norm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Grading by Dermatologist for efficacy (time frame: T-2w (2 weeks before procedure), T0 (baseline, before procedure), Timm (right after procedure), T5d (5 days after procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)). 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 26 Oct 2026.

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