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COMPLETED

NCT07889414

B5 Serum 4-week Clinical Study

Sponsor: ChinaNorm

View on ClinicalTrials.gov

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 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: * 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

Key Details

Gender

FEMALE

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2026-03-23

Completion Date

2026-06-01

Last Updated

2026-10-22

Healthy Volunteers

Yes

Conditions

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

Interventions

OTHER

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

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.

Inclusion Criteria: * 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. 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.

Locations (1)

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

Shanghai, Shanghai Municipality, China