Trial · NCT07895303
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Grading by Dermatologist for efficacy | 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) | 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. |
| Secondary | Facial Photos Tracking by ColorFace | 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) | 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. |
| Secondary | LC-OCT in vivo imaging measurement | 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) | 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. |
| Secondary | Facial Photos Tracking by E-mirror | 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) | 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. |
| Secondary | Skin Firmness (R0, Uf) measured by Cutometer® Dual MPA 580 | 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) | 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. |
| Secondary | TEWL Measurement by Tewameter® TM 300 | 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) | 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. |
| Secondary | Skin Hydration Measurement by Corneometer CM825 | 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) | 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. |
| Secondary | Skin Gross Elasticity (R2, Ua/Uf) measured by Cutometer® Dual MPA 580 | 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) | 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. |
| Secondary | Skin Net Elasticity (R5, Ur/Ue) measured by Cutometer® Dual MPA 580 | 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) | 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. |
| Secondary | Skin Biological Elasticity (R7, Ur/Uf) measured by Cutometer® Dual MPA 580 | 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) | 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. |
| Other | Clinical Grading by Dermatologist for safety | 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) | 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. |
| Other | Skin microbiome testing by swab sampling | 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 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. |
| Other | Skin proteomics testing by tape-stripping | 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 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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