ClinicalTrials.gg
CompletedNCT07874126Updated Oct 14, 2026

B5 Serum Instant Clinical Study

An interventional study of Topical skin soothing essence 1.0 and Topical skin soothing essence 2.0 in Mildly Sensitive Skin, 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 2026-10-14.

Sponsored by ChinaNorm · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2026, registered Oct 2026).
Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

The goal of this study is to explore the soothing effect of two test products within two hours after a single use by analyzing the changes in various indicators including clinical evaluation, non-invasive instrument measurement, image analysis and participant self-evaluation before and after product application.

The main questions it aims to answer are:

Can the two test products effectively relieve skin discomfort within two hours after a single use? What changes do multiple skin indicators show at different time points after the single application of the two test products? Researchers will adopt a single-center, split-face controlled study design. A total of about 124 healthy Chinese women aged 20-40 years will be enrolled and randomly divided into 2 groups with approximately 62 participants in each group.

Participants will:

Receive a single application of the assigned test product; Undergo skin indicator detection and clinical evaluation at scheduled time points within two hours after product application; Complete relevant self-evaluation questionnaires to record skin subjective feelings.

02

Conditions studied

  • Mildly Sensitive Skin
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • 1. Female Chinese subjects, aged 20-40 years old; 2. All skin types, with self-reported mild sensitive skin; 3. Self-reported tendency of easy skin flushing and erythema; 4. Full-face assessment by a dermatologist confirming the following skin characteristic:

    • Skin redness grade ≥4 (Griffiths 10-point scale) 7-8 minutes after the red-inducing challenge; 5. Agree to refrain from using any cosmetics, skincare products, beauty devices, topical medications and cleansing products throughout the test period; 6. No participation in any clinical trials or cosmetic tests within the past 1 month; 7. No contraindications for test participation as assessed by a dermatologist; 8. In good general health during the study period; 9. Voluntarily sign the informed consent form and photo usage authorization form; 10. Agree to comply with all test requirements specified in the protocol.

Exclusion criteria

Exclusion Criteria:

  • 1. Pregnant or lactating women, or women planning to become pregnant during the test period; 2. Individuals unable to participate in the trial per the study schedule or with other conditions unsuitable for trial participation (e.g., deprived of rights by law or administrative order, under guardianship, receiving care from health or social welfare institutions, or undergoing emergency treatment); 3. Participants with skin diseases or allergic conditions at the test site (especially acne, rosacea, eczema); 4. Participants assessed by the investigator to have stable or progressively deteriorating diseases; 5. Immunocompromised participants; 6. Participants with a history of allergy to cosmetics, personal care products, or their ingredients; 7. Participants assessed by the investigator to have had excessive exposure to sunlight or ultraviolet radiation; 8. Participants with a history of photosensitivity or skin allergy; 9. Participants who regularly engage in water sports or nautical activities; 10. Participants with a regular sauna habit; 11. Subjects prone to allergies; 12. Participants with a medical history of cardiovascular or blood circulation disorders; 13. Participants with a history of skin cancer or malignant melanoma; 14. Participants who received aesthetic medical treatment or participated in other studies within 6 months prior to the study; 15. Participants who took antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within 6 months before the study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    Arm 1

    Single topical application of Test Essence 1.0 on one side of the subject's face.

    Other: Topical skin soothing essence 1.0

  • Experimental
    Arm 2

    Single topical application of Test Essence 2.0 on one side of the subject's face.

    Other: Topical skin soothing essence 2.0

Interventions

  • OtherTopical skin soothing essence 1.0

    Topical skin soothing essence 1.0, applied once to one side of the subject's face in this split-face study, to evaluate its soothing effect on induced skin redness.

  • OtherTopical skin soothing essence 2.0

    Topical skin soothing essence 2.0, applied once to one side of the subject's face in this split-face study, to evaluate its soothing effect on induced skin redness.

06

What researchers measure

Primary outcomes

  1. Change in skin erythema measured by Mexameter® MX18

    Skin erythema is measured by Mexameter® MX18 at baseline (BL). Compare the change of skin a\* value between the side applied with Test Essence 1.0 and the side applied with Test Essence 2.0 in this split-face study, to evaluate the skin soothing effect on infrared-induced skin redness.

    Time frame: Baseline , post-induction (T0), 10 minutes, 1 hour and 2 hours after product application

Secondary outcomes

  1. Clinical skin redness score assessed by dermatologist

    Dermatologist assesses skin redness using modified Griffiths 10-point scale (0.5 increments allowed) at Baseline , post-induction , 10 minutes, 1 hour and 2 hours after product application. The same dermatologist evaluates the same subject and is blinded to prior scores. Compare score changes between two sides of face.

    Time frame: Baseline , post-induction , 10 minutes, 1 hour and 2 hours after product application

  2. Proportion of red area from VISIA 7 facial image analysis

    Facial images are captured by VISIA7 under standard, cross-polarized and UV light. IPP software is used to analyze red area proportion at Baseline , post-induction , 10 minutes, 1 hour and 2 hours after product application. Compare red area proportion changes between two facial sides.

    Time frame: Baseline , post-induction , 10 minutes, 1 hour and 2 hours after product application

  3. TiVi index (red blood cell concentration) measured by TiVi700

    TiVi700 is used to detect red blood cell concentration (TiVi index) of bilateral cheeks at Baseline , post-induction , 10 minutes, 1 hour and 2 hours after product application. Compare TiVi index changes between two sides.

    Time frame: Baseline , post-induction , 10 minutes, 1 hour and 2 hours after product application

  4. Skin temperature measured by FLUKE TIS60+ infrared camera

    Facial skin temperature is acquired by FLUKE TIS60+ infrared camera at Baseline , post-induction , 5 minutes,10 minutes, 1 hour and 2 hours after product application. Compare skin temperature changes between two facial sides.

    Time frame: Baseline , post-induction , 5 minutes,10 minutes, 1 hour and 2 hours after product application

  5. Subject self-assessment score of skin discomfort (0-4 scale)

    Subjects complete self-assessment questionnaire for stinging, itching, burning and tightness (0-4 scale) at Post-induction , 10 minutes, 1 hour and 2 hours after product application. Higher scores mean more severe discomfort.

    Time frame: Post-induction , 10 minutes, 1 hour and 2 hours after product application

  6. Subject questionnaire on product sensory experience

    Subjects complete self-reported questionnaire regarding skin condition after product use at 10 minutes, 1 hour and 2 hours after product application.

    Time frame: 10 minutes, 1 hour and 2 hours after product application

07

Study locations

1 site
  • Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
    Shanghai, Shanghai Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07874126
Lead sponsor
ChinaNorm
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Mar 20, 2026
Primary completion
Mar 29, 2026
Completion
Sep 29, 2026
Last update
Oct 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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