Assessment of Soothing, Moisturizing and Skin Barrier Repair Efficacy of Facial Skincare Products in Healthy WomenNCT07889414

B5 Serum 4-week Clinical Study

A study testing Topical facial serum (Serum 2.0) and Topical facial serum (Serum 1.0) in people with Assessment of Soothing, Moisturizing and Skin Barrier Repair Efficacy of Facial Skincare Products in Healthy Women, run by ChinaNorm at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Assessment of Soothing, Moisturizing and Skin Barrier Repair Efficacy of Facial Skincare Products in Healthy Women
What is being tested?: Topical facial serum (Serum 2.0) and Topical facial serum (Serum 1.0)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteChina
Study dates: 23 Mar 2026to 1 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

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 20 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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:
Redness (full face): grade≥4 (0-9 scale);
Global appearance of fine line: 3≤grade≤6 (0-9 scale);
Nasolabial fold: 1≤grade≤5 (Skin Aging Atlas, of 0 to 7 on Page 54 to 55);
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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
Shanghai, Shanghai Municipality

Other trials in China

About this study

Do the two test products provide soothing, moisturizing and skin barrier repair benefits after 4 weeks of continuous use?
Can Serum 2.0 sustain its efficacy at 1 week and 2 weeks after stopping application?

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:

Apply the allocated test product on the full face continuously for 4 weeks
Attend scheduled on-site visits to receive clinical assessment, instrumental measurement, image analysis, lactic acid stinging test and fill in questionnaires
Conduct skin status self-assessment at each visit

Conditions: Assessment of Soothing, Moisturizing and Skin Barrier Repair Efficacy of Facial Skincare Products in Healthy Women
Being tested: Topical facial serum (Serum 2.0), Topical facial serum (Serum 1.0)

What participants receive

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

Topical facial serum (Serum 2.0)Other
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.
Topical facial serum (Serum 1.0)Other
Facial soothing \& repairing serum, applied topically on full face once daily for 4 weeks, no post-discontinuation follow-up.

Study groups in NCT07889414
Study group	Role	What they receive
Group A :Test Product Serum 2.0 Group	Experimental	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. Receives: Other: Topical facial serum (Serum 2.0)
Group B:Test Product Serum 1.0 Group	Active comparator	Participants apply test product Serum 1.0 on full face continuously for 4 weeks. No follow-up visits after stopping product application. Receives: Other: Topical facial serum (Serum 1.0)

What is being measured

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

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.
Measured: 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.

Secondary outcomes (9)

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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.

Timeline

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

23 Mar 20261 Jun 2026

First posted22 Oct 2026
Study start23 Mar 2026
Primary completion1 Jun 2026
Study completion1 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Assessment of Soothing, Moisturizing and Skin Barrier Repair Efficacy of Facial Skincare Products in Healthy WomenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07889414
Sponsor's protocol ID: C26005014
Status last verified: Oct 2026
First submitted: 16 Oct 2026
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: B5 Serum 4-week Clinical Study
ClinicalTrials.gov ID: NCT07889414
Acronym / sponsor ID: C26005014
Conditions: Assessment of Soothing, Moisturizing and Skin Barrier Repair Efficacy of Facial Skincare Products in Healthy Women
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: ChinaNormIndustry (pharma, biotech, devices)
Study start: 23 Mar 2026 (actual)
Primary completion: 1 Jun 2026 (actual)
Study completion: 1 Jun 2026 (actual)
First posted: 22 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Do the two test products provide soothing, moisturizing and skin barrier repair benefits after 4 weeks of continuous use?
Can Serum 2.0 sustain its efficacy at 1 week and 2 weeks after stopping application?

Participants will:

Apply the allocated test product on the full face continuously for 4 weeks
Attend scheduled on-site visits to receive clinical assessment, instrumental measurement, image analysis, lactic acid stinging test and fill in questionnaires
Conduct skin status self-assessment at each visit

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A :Test Product Serum 2.0 Group	Experimental	Other: Topical facial serum (Serum 2.0)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.
Group B:Test Product Serum 1.0 Group	Active comparator	Other: Topical facial serum (Serum 1.0)Participants apply test product Serum 1.0 on full face continuously for 4 weeks. No follow-up visits after stopping product application.

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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:
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.

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topical facial serum (Serum 2.0)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.	Other	Group A :Test Product Serum 2.0 Group
Topical facial serum (Serum 1.0)Facial soothing \& repairing serum, applied topically on full face once daily for 4 weeks, no post-discontinuation follow-up.	Other	Group B:Test Product Serum 1.0 Group

Primary outcome

Dermatologist-assessed clinical skin attribute scores
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.
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.

9 secondary outcomes

Skin hydration measured by Corneometer CM825
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
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
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
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
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
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
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)
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
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 6 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: finished, as of the sponsor's last update on 22 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dermatologist-assessed clinical skin attribute scores (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07889414.

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 22 Oct 2026.