Trial · NCT07889414
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 | Dermatologist-assessed clinical skin attribute scores | 2 weeks before baseline , at baseline, 15 minutes after product application, 1 day, 1 week, and 4 weeks post-baseline. Group A additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B has no assessments at these two time points. | ermatologist clinical grading of skin texture \& quality, wrinkle and lifting attributes using modified Griffiths 10-point scale. Evaluated items include skin redness, radiance, brightness, dullness, softness, elasticity, firmness, plumpness, fine lines, forehead wrinkle, glabellar wrinkle, nasolabial fold, global sagging and jawline sagging. |
| Secondary | Skin hydration measured by Corneometer CM825 | Baseline (T0), Week 1 after baseline (T1w), Week 4 after baseline (T4w). Group A (Serum 2.0) has additional measurements at Week 5 after baseline (T5w) and Week 6 after baseline (T6w); Group B (Serum1.0) has no measurements at Week5 and Week6. | Skin hydration (stratum corneum moisture content) is quantified by capacitance measurement using Corneometer CM825 (Courage\&Khazaka, Germany). Test sites (left/right cheek) are randomly assigned at baseline and kept consistent across all visits. Three consecutive valid readings are collected and averaged, with the deviation of three measurements less than 10%. |
| Secondary | Skin transepidermal water loss (TEWL) measured by Vapometer | Baseline (T0), Week 1 after baseline (T1w), Week 4 after baseline (T4w). Group A (Serum 2.0) has additional measurements at Week 5 after baseline (T5w) and Week 6 after baseline (T6w); Group B (Serum1.0) has no measurements at Week5 and Week6. | TEWL is measured by Vapometer (Delfin Technologies, Finland) equipped with a closed cylindrical chamber. TEWL is calculated based on the rising relative humidity inside the chamber when contacting skin; lower TEWL indicates better skin barrier function. Left/right cheek test site is randomly assigned at baseline and remains consistent for all visits. Two measurements are acquired at each test site. |
| Secondary | Skin melanin and haemoglobin measured by Mexameter® MX 18 | At baseline, 15 minutes after product application, 1 day, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | Mexameter® MX 18 (Courage + Khazaka, Germany) uses absorption/reflection spectrophotometry. The probe emits 3 specific wavelengths and detects reflected light. Melanin is assessed with 660 nm red light and 880 nm near-infrared light; erythema/haemoglobin uses 568 nm green light and 660 nm red light to reduce interference. Left/right cheek site is randomized at baseline and fixed for all visits. Three measurements are taken per test area. |
| Secondary | Facial image capture by VISIA®-CRP | At baseline, 15 minutes after product application, 1 day, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | Facial photographs are captured by trained technicians using VISIA®-CRP (Canfield, America). Subjects wear headbands and close eyes. Left, central and right facial views are acquired with 4 built-in light modes: Standard light, Cross-Polarized light, Parallel-Polarized light and UV-Absorption light. Test side is randomized at baseline and kept consistent throughout the study. |
| Secondary | Skin thickness and density measured by Ultrascan UC22 | At baseline, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | Skin thickness and density are assessed with Ultrascan UC22 (Courage + Khazaka) at 22 MHz. Ultrasound reflections are converted into B-scan colour images to visualise skin up to 6-8 mm depth. Left/right cheek site is randomized at baseline and fixed across all visits. |
| Secondary | Skin imaging by SUPERVISION780 two-photon microscopic imaging system | At baseline, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | SUPERVISION780 (Beijing Transcend Vivoscope Bio-Technology Co., Ltd) is a portable miniaturized two-photon microscope for in vivo, non-invasive, label-free assessment of skin structure and 3D component distribution. It works based on two-photon absorption: near-infrared light excites simultaneous two-photon absorption to generate fluorescence. Optical slicing and 3D imaging are achieved as excitation only occurs within the high-intensity focal region. One side of the cheek is tested. Left/right cheek site is randomized at baseline and kept consistent across all visits. |
| Secondary | Skin surface imaging by VisioScan VC20 | At baseline, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | VisioScan VC20 (Courage\&Khazaka, Germany) is a CCD skin imaging system equipped with a UV light source within a dedicated probe to capture skin surface images. Black-and-white video signals are digitized and transferred to a computer; skin surface status is analysed by SELS dedicated skin evaluation software. Subjects sit firmly against the chair back to maintain stable body and head position before image acquisition. Left/right cheek site is randomized at baseline and kept consistent across all visits. This is a demo subgroup with total 20 subjects (10 subjects per group). |
| Secondary | Facial skin imaging by CASIO (DZ-d100) | At baseline, 1 day, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | CASIO (DZ-d100, Casio, Japan) is a digital camera for skin observation, with proprietary camera and image processing technology. It can capture polarized, non-polarized and UV images at identical viewing angle. Recording mode: DERMO CONT; Digital zoom: 2x; Light: Mid; Shooting light source: polarized, non-polarized. This is a demo subgroup with total 20 subjects (10 subjects per group). |
| Secondary | Lactic Acid Sting Test (LAST) for skin sensitivity assessment | Screening visit for subject eligibility screening; assessments at 1 day, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B(Serum1.0)has no assessments at these two time point. | The Lactic Acid Sting Test is an accepted marker of skin sensitivity, used to screen subjects with subclinical sensory irritation. 50 μL of 10% lactic acid solution and distilled water are applied to medical filters placed on bilateral nasal grooves. Subjects rate stinging, itching and burning symptoms at 0-30 seconds, 2.5 minutes and 5 minutes after application. Stinging, itching, burning and total scores are calculated. Subjects with stinging score ≥3 (at 2.5 min +5 min) are enrolled. Left/right assignment is randomized and fixed throughout the study. Screening assessment is performed at screening visit. |
| Other | Dermatologist safety assessment (Group A only) | At baseline and 4 weeks post-baseline. This assessment is not conducted in Group B. | This assessment is only performed for Group A (N=40). At each assessment visit, the dermatologist asks subjects whether they currently feel any discomfort. If discomfort is reported, the type (tightness, stinging, burning, itching or others), intensity and location are documented. The dermatologist also records the exact site and type of observed physical signs including redness, erythema, edema, dryness, desquamation, pimples or other symptoms. |
| Other | Subject self-grading of skin sensations | At baseline, 15 minutes after product application, 1 day, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally has assessments at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | Subjects self-rate the intensity of stinging, itching, burning and tightness. Intensity scale: 0 = none; 1 = very slight; 2 = slight; 3 = moderate; 4 = severe. |
| Other | Consumer questionnaire | 15 minutes after product application, 1 day, 1 week, and 4 weeks post-baseline. Group A (Serum2.0) additionally completes it at 5 weeks and 6 weeks post-baseline; Group B (Serum1.0) has no assessments at these two time points. | This self-administered questionnaire consists of three modules: demographic information, health cognition and health behaviors, with a total of 24 items, including 4 demographic items and 20 scale items. The scale adopts Likert 1-5 scoring (1=strongly disagree,5=strongly agree). Four reverse items require score reversal. Subscale scores are calculated by summing corresponding items, and total score ranges from 20 to 100. Higher total score indicates higher level of health cognition. |
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.
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