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COMPLETED

NCT07874126

B5 Serum Instant Clinical Study

Sponsor: ChinaNorm

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2026-03-20

Completion Date

2026-09-29

Last Updated

2026-10-14

Healthy Volunteers

Yes

Conditions

Mildly Sensitive Skin

Interventions

OTHER

Topical 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.

OTHER

Topical 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.

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: * 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.

Locations (1)

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

Shanghai, Shanghai Municipality, China