An interventional study of CO₂ fractional laser skin treatment and Thermage skin tightening treatment in Skin Physiology After Fractional CO₂ Laser Treatment and Skin Physiology After Thermage Treatment, sponsored by ChinaNorm. Recruiting at 1 site in China. Open to female participants aged 30 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by ChinaNorm · Not applicable, Interventional, and Other
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:
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:
ChinaNorm is the lead sponsor of 30 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects 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).
Device: CO₂ fractional laser skin treatment · Other: Neutral broad-spectrum sunscreen · Other: Neutral moisturizing cream
Subjects 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).
Device: Thermage skin tightening treatment · Other: Neutral broad-spectrum sunscreen · Other: Neutral moisturizing cream
Single session of superficial CO₂ fractional laser for skin aesthetic improvement. All subjects maintain neutral skincare products throughout wash-out and follow-up periods.
Single session of superficial Thermage for skin aesthetic improvement. All subjects maintain neutral skincare products throughout wash-out and follow-up periods.
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.
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.
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.
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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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)
Clinical Grading by Dermatologist for safety
The listed skin symptoms and sensations will be evaluated and inquired. The grading uses a 0 to 4 scoring scale (score 0 = no symptom, score 4 = very serious). Assessments are performed by one validated dermatologist.
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)
Skin microbiome testing by swab sampling
Skin microbiome swab sampling will be performed by trained technician on one side of cheek. Left/right cheek is assigned per subject by randomization table at T0 and kept consistent for all visits. Subjects are required to avoid face washing 12h before sampling, no skincare or makeup products on visit day. Sampling uses injection-grade sterile normal saline. Swab is wiped on upper and lower cheek sampling area, 360° rotation for about 10 turns each area. Swab is put into preservation solution, stored at -80℃ after collection. All 300 samples will undergo shotgun metagenomic sequencing for library construction and sequencing.
Time frame: T0 (baseline, before procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)
Skin proteomics testing by tape-stripping
Skin proteomics sampling by tape-stripping will be conducted by a trained technician on one side of the cheek. The left or right cheek for each subject is assigned at T0 per randomization table and remains consistent across all visits. D-Squame tape is peeled using pliers. The first tape strip is applied with standardized weight for 10 seconds and discarded. The 2nd and 3rd tape strips are sampled sequentially at the same site under identical standardized weight for 10 seconds each. Collected tapes are immediately transferred into clean 2 mL EP tubes. Tubes are temporarily stored on dry ice, then transferred to a -80°C freezer for long-term preservation.
Time frame: T0 (baseline, before procedure), T10d (10 days after procedure), T28d (28 days after procedure), T56d (56 days after procedure), T84d (84 days after procedure)
Plan to share: No
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