An interventional study of Topical facial serum (Serum 2.0) and Topical facial serum (Serum 1.0) in Assessment of Soothing, Moisturizing and Skin Barrier Repair Efficacy of Facial Skincare Products in Healthy Women, sponsored by ChinaNorm. Completed at 1 site in China. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by ChinaNorm · Not applicable, Interventional, and Other
The goal of this clinical study is to evaluate the soothing, moisturizing and skin barrier repair effects of two test products by measuring changes in multiple indicators before and after product use, including clinical assessment, non-invasive instrumental measurement, image analysis, lactic acid stinging test and participant self-assessment. It will also explore the residual effect after 2 weeks of discontinuation (only for Serum 2.0). The main questions it aims to answer are:
This is a single-center clinical efficacy study with a 2-week washout period. Approximately 124 healthy Chinese female participants aged 20-40 years will be enrolled and randomly allocated into 2 groups, with around 62 participants in each group. At least 40 participants per group will complete the clinical testing part, and 60 participants per group will complete the questionnaire part.
Researchers will compare skin parameters at multiple time points: baseline (T0), immediately after use (Timm), 1 day after use (T1d), 1 week after use (T1w), 4 weeks after use (T4w), 1 week after discontinuation (T5w, Group A only), and 2 weeks after discontinuation (T6w, Group A only).
Participants will:
ChinaNorm is the lead sponsor of 28 studies on the registry; 12 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.
1. Chinese female, 20-40 years old. 2. All skin types with 100% sensitive skin (self-declared). 3. Presenting with corresponding severity for the attribute evaluated by Dermatologist included:
Forehead wrinkles: 1≤grade≤5 (Skin Aging Atlas, of 0 to 8 on Page 32 to 33); 4. The sum of the 2.5min and 5min stinging scores (lactic acid side minus distilled water side)≥3 after LAST test. 5. Presenting with lack of radiance, smoothness, brightness, softness, elasticity, firmness and plumpness on the face, evaluated by dermatologist. 6. Presenting with sagging, evaluated by dermatologist. 7. All accept not to use any cosmetics, skincare products, beauty equipment, all topical medications and cleansing products on face during the test. 8. Did not participate in any clinical test or cosmetic product test on skin within 1 month.
9. No disagreement of dermatologist because of other reasons that exclude the participation of the volunteer. 10. In general, good health at the time of the study. 11. Willing and able to participate as evidenced by signing of informed consent and photo release form.
12. Must be willing to comply with all study protocol requirements.
Exclusion Criteria:
1. Pregnant or breast-feeding woman or woman planning pregnancy during the study.
2. Subject deprived of rights by a court or administrative order. 3. Major subject to a guardianship order. 4. Subject residing in a health or social care establishment. 5. Patient in an emergency setting. 6. Volunteer with a skin disease in the test areas as well as skin allergy (particularly e.g., acne, rosacea, eczema).
7. Volunteer presenting a stable or progressive serious disease (per investigator's assessment).
8. Immuno-compromised subject. 9. Subject with history of allergy to cosmetic or personal care products or ingredients.
10. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
11. Subject with history of sunlight sensitivity or allergies. 12. Subjects regularly practicing aquatic or nautical sports. 13. Subjects regularly attending a sauna. 14. Subject with physical highly sensitive constitution. 15. Subject with cardiovascular or circulatory history. 16. Subject with a history of skin cancer or malignant melanoma. 17. Subject with history of medical beauty treatment and taking part in other studies in the last 6 months before study. 18. Use of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within 6 months prior to the study.
Participants apply test product Serum 2.0 on full face continuously for 4 weeks. Follow-up visits will be conducted at 1 week and 2 weeks after discontinuation of product use.
Other: Topical facial serum (Serum 2.0)
Participants apply test product Serum 1.0 on full face continuously for 4 weeks. No follow-up visits after stopping product application.
Other: Topical facial serum (Serum 1.0)
Facial soothing \& repairing serum, applied topically on full face once daily for 4 weeks, followed by 2-week post-treatment follow-up to assess sustained efficacy.
Facial soothing \& repairing serum, applied topically on full face once daily for 4 weeks, no post-discontinuation follow-up.
Dermatologist-assessed clinical skin attribute scores
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.
Time frame: 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.
Skin hydration measured by Corneometer CM825
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%.
Time frame: 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 transepidermal water loss (TEWL) measured by Vapometer
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.
Time frame: 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 melanin and haemoglobin measured by Mexameter® MX 18
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.
Time frame: 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 image capture by VISIA®-CRP
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.
Time frame: 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.
Skin thickness and density measured by Ultrascan UC22
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.
Time frame: 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 imaging by SUPERVISION780 two-photon microscopic imaging system
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.
Time frame: 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 surface imaging by VisioScan VC20
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).
Time frame: 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.
Facial skin imaging by CASIO (DZ-d100)
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).
Time frame: 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.
Lactic Acid Sting Test (LAST) for skin sensitivity assessment
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.
Time frame: 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.
Dermatologist safety assessment (Group A only)
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.
Time frame: At baseline and 4 weeks post-baseline. This assessment is not conducted in Group B.
Subject self-grading of skin sensations
Subjects self-rate the intensity of stinging, itching, burning and tightness. Intensity scale: 0 = none; 1 = very slight; 2 = slight; 3 = moderate; 4 = severe.
Time frame: 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.
Consumer questionnaire
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.
Time frame: 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.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.